Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Introducer, Catheter

FDA product code DYB · 659 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1340
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-03-16 – 2026-07-29

DYB 2000-06-16

TEARAWAY INTRODUCER SHEATH

Applicant Xentek Medical, Inc.

K number K000313

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DYB 2000-05-31

FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX

Applicant St. Jude Medical, Inc.

K number K001367

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DYB 2000-05-26

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)

Applicant Innerdyne, Inc.

K number K992668

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DYB 2000-05-24

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX

Applicant St. Jude Medical, Inc.

K number K001346

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DYB 2000-05-15

ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX

Applicant Daig Corp.

K number K994334

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DYB 2000-05-10

PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M

Applicant Biosense Webster, Inc.

K number K001139

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DYB 2000-04-13

PERCUTANEOUS INTRODUCER, MODEL 10383-XXX

Applicant Medamicus, Inc.

K number K000824

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DYB 2000-03-24

TFX MEDICAL INTRODUCER ASSEMBLY

Applicant Tfx Medical, Inc.

K number K993191

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DYB 2000-03-15

IN-LINE HEMOSTASIS VALVE

Applicant Merit Medical Systems, Inc.

K number K990975

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DYB 2000-01-04

INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE

Applicant Boston Scientific Corp

K number K994252

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DYB 2000-01-04

TFX MEDICAL INTRODUCER KIT

Applicant Tfx Medical Group

K number K991647

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DYB 1999-10-07

INTRODUCER SHEATH, VESSEL DILATOR

Applicant Boston Scientific Corp

K number K992309

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DYB 1999-07-15

EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR

Applicant Adam Spence Corp.

K number K983940

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DYB 1999-06-28

MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET

Applicant Medamicus, Inc.

K number K990705

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DYB 1999-05-07

EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF

Applicant Schneider/Namic

K number K983039

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DYB 1999-03-24

SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229

Applicant Diag Corp.

K number K984062

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DYB 1999-01-26

PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)

Applicant Terumo Medical Corp.

K number K984260

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DYB 1998-12-23

CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

Applicant Cordis Corp.

K number K984500

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DYB 1998-11-30

BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB

Applicant Luther Medical Products, Inc.

K number K982797

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DYB 1998-11-24

BAXTER HEMOSTASIS VALVE INTRODUCERS

Applicant Baxter Edwards

K number K981909

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DYB 1998-10-01

MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

Applicant Cordis Corp.

K number K983023

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DYB 1998-09-16

FAST-CATH INTRA-CARDIAC INTRODUCER

Applicant Daig Corp.

K number K982187

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DYB 1998-09-11

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)

Applicant Innerdyne, Inc.

K number K980578

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DYB 1998-08-28

CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S

Applicant Cordis Webster, Inc.

K number K982740

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DYB 1998-08-12

LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM

Applicant Arrow Intl., Inc.

K number K981782

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DYB 1998-08-07

EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET

Applicant Schneider/Namic

K number K980504

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DYB 1998-05-21

FAST-CATH (TM) INTRA-CARDIAC INTRODUCER

Applicant Daig Corp.

K number K973840

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DYB 1998-02-13

ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET

Applicant Arrow Intl., Inc.

K number K970229

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DYB 1998-02-06

CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

Applicant Cordis Corp.

K number K974448

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DYB 1997-11-06

DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER

Applicant Datascope Corp.

K number K973007

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DYB 1997-10-28

CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM

Applicant Cordis Webster, Inc.

K number K970264

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DYB 1997-10-10

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM

Applicant Innerdyne, Inc.

K number K972684

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DYB 1997-10-01

HEARTPORT INTRODUCER SHEATH

Applicant Heartport, Inc.

K number K972570

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DYB 1997-07-25

PERCUTANEOUS VENOUS INTRODUCER 10264

Applicant Medamicus, Inc.

K number K965167

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DYB 1997-07-21

CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

Applicant Cordis Corp.

K number K971608

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DYB 1997-05-14

FAST-CATH TRANSSEPTAL CATHETER INTRODUCER

Applicant Daig Corp.

K number K964518

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DYB 1997-05-07

BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

Applicant Bipore, Inc.

K number K964814

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DYB 1997-05-06

TRANSJUGULAR ACCESS SET

Applicant AngioDynamics, Inc.

K number K964034

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DYB 1997-04-24

EVS

Applicant Applied Medical Resources

K number K963886

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DYB 1997-04-21

GSI CANNULA WITH INTRODUCER

Applicant General Surgical Innovations

K number K970201

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DYB 1997-01-07

CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM

Applicant Johnson & Johnson Medical, Inc.

K number K962978

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DYB 1996-12-24

HEMODIALYSIS INTRODUCER SET

Applicant Thomas Medical Products, Inc.

K number K961780

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DYB 1996-11-07

CATH SEAL

Applicant Universal Medical Instrument Corp.

K number K962180

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DYB 1996-10-11

CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT

Applicant Cordis Corp.

K number K962746

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DYB 1996-09-17

BRAUN PERCUTANEOUS INTRODUCER SET

Applicant B.Braun Medical, Inc.

K number K961745

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DYB 1996-09-12

PERCUTANEOUS INTRODUCER SET

Applicant Thomas Medical Products, Inc.

K number K961466

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DYB 1996-08-12

INPUT TUOHY-BORST LOCKING DEVICE

Applicant C.R. Bard, Inc.

K number K960445

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DYB 1996-08-08

SPREADABLE SHEATH INTRODUCER SET

Applicant Neostar Medical Technologies, Inc.

K number K960625

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DYB 1996-07-02

INTROSTAT LEAD INTRODUCER

Applicant Msi, Inc.

K number K960200

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DYB 1996-05-13

PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET

Applicant Ep Medsystems

K number K961513

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DYB 1996-04-30

INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)

Applicant C.R. Bard, Inc.

K number K961135

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DYB 1996-04-12

BRAUN HEMOSTASIS INTRODUCERS

Applicant B.Braun Medical, Inc.

K number K960406

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DYB 1996-04-08

FIRST PICC INTRODUCER CATHETER

Applicant Becton Dickinson Vascular Access, Inc.

K number K954906

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DYB 1996-03-25

BRAUN HEMOSTASIS INTRODUCERS

Applicant B.Braun Medical, Inc.

K number K955820

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DYB 1996-03-12

TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET

Applicant C.R. Bard, Inc.

K number K955785

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DYB 1996-02-07

EPIC INTRODUCER SHEATH

Applicant North American Instrument Corp.

K number K960310

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DYB 1995-12-28

CORDIS BRITE TIP SHEATH INTRODUCER

Applicant Cordis Corp.

K number K954595

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DYB 1995-12-28

NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE

Applicant Novoste Corp.

K number K942977

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DYB 1995-11-28

DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS

Applicant Daig Corp.

K number K954317

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DYB 1995-11-27

RADIFOCUS INTRODUCER II KIT

Applicant Terumo Medical Corp.

K number K954234

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DYB 1995-08-18

MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM

Applicant Boston Scientific Corp

K number K952828

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DYB 1995-08-10

USCI INPUT INTRODUCER SET

Applicant Usci, Div. C.R. Bard, Inc.

K number K940092

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DYB 1995-08-02

RAPID-TRAK(TM) INTRODUCER SHEATH

Applicant Cardio Vascular Concepts, Inc.

K number K950155

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DYB 1995-06-27

MEDAMICUS PERCUTANEOUS INTRODUCER

Applicant Medamicus, Inc.

K number K951313

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DYB 1995-04-26

CORDIS INTRODUCING CATHETER

Applicant Cordis Corp.

K number K945524

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DYB 1995-03-29

CORDIS AVANTI CATHETER SHEATH INTRODUCER

Applicant Cordis Corp.

K number K945616

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DYB 1995-03-13

FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET

Applicant B.Braun Medical, Inc.

K number K945396

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DYB 1995-02-21

INTRODUCER NEEDLE (SEVERAL SIZES)

Applicant Mediziv Medical Products 1987 , Ltd.

K number K933522

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DYB 1994-11-30

ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903

Applicant Arrow Intl., Inc.

K number K940079

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DYB 1994-09-21

URESIL DILATOR

Applicant Uresil Corp.

K number K942191

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DYB 1994-09-14

VIP PLUS PERCUTANEOUS INTRODUCER

Applicant Medamicus, Inc.

K number K944107

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DYB 1994-07-06

EXACTA PERCUTANEOUS INTRODUCER SHEATH

Applicant Ohmeda Medical

K number K941428

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DYB 1994-06-07

CATH-SEAL

Applicant Universal Medical Instrument Corp.

K number K935077

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DYB 1994-04-13

ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE

Applicant Advanced Cardiovascular Systems, Inc.

K number K934624

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DYB 1994-03-15

PROTECTOR INTRODUCER SHEATH

Applicant Boston Scientific /International Technologies

K number K930808

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DYB 1994-01-21

TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE

Applicant Thomas Medical Products, Inc.

K number K934901

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DYB 1993-11-24

CATHETER INTRODUCER MODIFICATION

Applicant Daig Corp.

K number K934285

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DYB 1993-11-09

REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET

Applicant Remington Medical, Inc.

K number K932370

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DYB 1993-11-09

PERCUTANEOUS INTRODUCER

Applicant Medamicus, Inc.

K number K932323

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DYB 1993-11-02

BURRON CARDIOVASCULAR ANGESTAT(TM)

Applicant B.Braun Medical, Inc.

K number K931743

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DYB 1993-10-15

INTHERM RADIALLY EXPANDING DILATING INTRODUCER

Applicant Innerdyne Medical, Inc.

K number K931489

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DYB 1993-10-06

MULTI-PORT Y INTRODUCER SET

Applicant Thomas Medical Products, Inc.

K number K931587

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DYB 1993-09-22

INTROPEEL V

Applicant Menlo Care, Inc.

K number K931218

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DYB 1993-09-22

INTROPEEL

Applicant Menlo Care, Inc.

K number K930801

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DYB 1993-09-22

HEMOSTASIS VALVE AND TUBING SET

Applicant Opticon Medical, Inc.

K number K930194

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DYB 1993-08-31

LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES

Applicant Pace Medical

K number K931662

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DYB 1993-08-26

CORDIS CATHETER SHEATH INTRODUCER

Applicant Cordis Corp.

K number K932733

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DYB 1993-08-06

ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET

Applicant B.Braun Medical, Inc.

K number K930057

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DYB 1993-06-25

BALT INTRODUCER

Applicant Target Therapeutics

K number K925633

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DYB 1993-05-27

CORDIS NIHON CATHETER SHEATH INTRODUCER

Applicant Cordis Corp.

K number K931102

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DYB 1993-05-27

NEW LEAD INTRODUCER KITS, VARIOUS MODELS

Applicant Telectronics Pacing Systems, Inc.

K number K926340

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DYB 1993-04-22

ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET

Applicant Arrow Intl., Inc.

K number K924607

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DYB 1993-03-22

LONG LENGTH PERCUTANEOUS INTRODUCER SET

Applicant Thomas Medical Products, Inc.

K number K924456

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DYB 1993-03-08

INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION

Applicant Kontron Instruments, Inc.

K number K923603

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DYB 1993-02-25

CATHETER INTRODUCER

Applicant Luther Medical Products, Inc.

K number K924562

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DYB 1993-01-21

EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI

Applicant Exonix Research Corp.

K number K923681

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DYB 1992-11-18

INTRODUCER, PERCUTANEOUS -- MODIFICATION

Applicant Medamicus, Inc.

K number K924491

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DYB 1992-10-06

OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1

Applicant Teleflexmedical, Inc.

K number K920908

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DYB 1992-10-06

OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO

Applicant Teleflexmedical, Inc.

K number K920907

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DYB 1992-08-24

TEC ROTATING DUAL HEMOVALVE

Applicant Intensive Technology, Inc.

K number K912664

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