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 1992-08-12

CATHETER INTRODUCER

Applicant Boston Scientific Corp

K number K920528

View details →

DYB 1992-06-10

MORSE HEMOSTATIC CATHETER INTRODUCER SET

Applicant North American Instrument Corp.

K number K915078

View details →

DYB 1992-06-03

GORE TUNNELER, MODIFICATION

Applicant W. L. Gore & Associates, Inc.

K number K920998

View details →

DYB 1992-06-03

FAST-CATH HEMOSTASIS INTRODUCER

Applicant Daig Corp.

K number K920779

View details →

DYB 1992-06-03

INTRODUCER CATHETER

Applicant Interventional Therapeutics Corp.

K number K915625

View details →

DYB 1992-04-16

DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER

Applicant Daig Corp.

K number K920327

View details →

DYB 1992-03-18

USCI HEMAQUET XT INTRODUCER

Applicant C.R. Bard, Inc.

K number K920251

View details →

DYB 1992-02-27

GUIDEWIRE INTRODUCER SET

Applicant B. Braun of America, Inc.

K number K915421

View details →

DYB 1992-02-21

USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING

Applicant C.R. Bard, Inc.

K number K915553

View details →

DYB 1992-01-27

GESCO PER-Q-CATH CATHETER INTRODUCER

Applicant Gesco Intl., Inc.

K number K915167

View details →

DYB 1991-12-20

SOS BLOODLESS NEEDLE

Applicant E-Z-Em, Inc.

K number K914330

View details →

DYB 1991-11-29

DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER

Applicant Diag Corp.

K number K911883

View details →

DYB 1991-11-22

CORDIS OBTURATOR

Applicant Cordis Corp.

K number K914352

View details →

DYB 1991-11-08

THE BIG EASY Y-ADAPTER

Applicant Microvena Corp.

K number K914046

View details →

DYB 1991-10-28

DAIG FAST CATH(TM) INTRODUCER, MODIFICATION

Applicant Daig Corp.

K number K914090

View details →

DYB 1991-10-16

CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL

Applicant Cordis Corp.

K number K913801

View details →

DYB 1991-09-11

MORSE VASCULAR INTRODUCER SET

Applicant North American Instrument Corp.

K number K912961

View details →

DYB 1991-07-19

CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE

Applicant Cordis Corp.

K number K911794

View details →

DYB 1991-07-12

ROTATING HEMOSTATIC VALVE

Applicant Devices For Vascular Intervention, Inc.

K number K911678

View details →

DYB 1991-06-18

MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS

Applicant Medtronic Vascular

K number K911236

View details →

DYB 1991-06-03

OLYMPUS ANGIOSCOPY IRRIGATION SHEATH

Applicant Olympus Corp.

K number K910933

View details →

DYB 1991-05-16

CORDIS PEEL-AWAY INSERTION TOOL

Applicant Cordis Corp.

K number K910688

View details →

DYB 1991-05-07

PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK

Applicant Daig Corp.

K number K910861

View details →

DYB 1991-04-01

ENTREE SHEATH INTRODUCER SYSTEM

Applicant Cordis Corp.

K number K904475

View details →

DYB 1991-01-03

IVT INTRODUCER SHEATH

Applicant Intensive Technology, Inc.

K number K903463

View details →

DYB 1990-10-31

BIO-MEDICUS CANNULA INTRODUCER

Applicant Bio Medicus, Inc.

K number K903410

View details →

DYB 1990-10-22

PERCUTANEOUS INTRODUCERS

Applicant Davol, Inc.

K number K903530

View details →

DYB 1990-10-16

GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY

Applicant Intec Medical, Inc.

K number K903840

View details →

DYB 1990-10-16

DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL

Applicant Datascope Corp.

K number K902932

View details →

DYB 1990-09-26

PERCUTANEOUS CATHETER INTRODUCER KIT

Applicant Intec Medical, Inc.

K number K903906

View details →

DYB 1990-09-26

PERCUTANEOUS INTRODUCER SET

Applicant Thomas Medical Products, Inc.

K number K902275

View details →

DYB 1990-08-24

WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET

Applicant Medical Engineering and Development Institute

K number K902477

View details →

DYB 1990-08-23

ARIES TAPERSEAL(TM) SHEATH

Applicant Aries Medical, Inc.

K number K903442

View details →

DYB 1990-08-23

INTRODUCER, PERCUTANEOUS

Applicant Novoste Puerto Rico, Inc.

K number K900658

View details →

DYB 1990-08-23

MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)

Applicant Medtronic Vascular

K number K900515

View details →

DYB 1990-08-08

ITC INTRODUCER CATHETER

Applicant Interventional Therapeutics Corp.

K number K900756

View details →

DYB 1990-07-31

SUBCLAVIAN INTRODUCER SET

Applicant Infusaid Corp.

K number K902251

View details →

DYB 1990-06-26

DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER

Applicant Datascope Corp.

K number K901391

View details →

DYB 1990-05-22

USCI(R) ACCESS(TM) INTRODUCER SET

Applicant C.R. Bard, Inc.

K number K901452

View details →

DYB 1990-04-30

Y-ADAPTER W/THOUY BORST

Applicant Angeion Corp.

K number K895580

View details →

DYB 1990-03-16

HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS

Applicant C.R. Bard, Inc.

K number K897041

View details →

DYB 1990-02-26

DUAL GUIDE INTRODUCER CATHETER

Applicant Cook, Inc.

K number K895044

View details →

DYB 1989-12-05

MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM

Applicant Boston Scientific Corp

K number K891121

View details →

DYB 1989-11-30

ANGEION HEMOSTASIS VALVE INTRODUCER

Applicant Angeion Corp.

K number K894446

View details →

DYB 1989-11-14

HEMOSTASIS VALVE

Applicant Applied Vascular Devices, Inc.

K number K895214

View details →

DYB 1989-10-02

MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE

Applicant Mallinckroot, Inc.

K number K894445

View details →

DYB 1989-09-28

OBTURATOR

Applicant Argon Medical Corp.

K number K894157

View details →

DYB 1989-09-26

DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO

Applicant Daig Corp.

K number K894343

View details →

DYB 1989-09-18

CATHETER INTRODUCER SHEATH

Applicant Applied Vascular Devices, Inc.

K number K890766

View details →

DYB 1989-09-06

MODIFIED LABELING TO PERMANENT LEAD INTRODUCER

Applicant Daig Corp.

K number K894431

View details →

DYB 1989-08-09

MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY

Applicant Daig Corp.

K number K894430

View details →

DYB 1989-08-09

INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD

Applicant Baxter Healthcare Corp

K number K885179

View details →

DYB 1989-08-03

PERCUTANEOUS INTRODUCER

Applicant Medamicus, Inc.

K number K893658

View details →

DYB 1989-05-19

INTRODUCER FOR PTCA GUIDING CATHETERS

Applicant Argon Medical Corp.

K number K891022

View details →

DYB 1989-03-10

HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT

Applicant Oscor Medical Corp.

K number K890277

View details →

DYB 1989-02-22

DAIG OBTURATOR, CATHETER INTRODUCER

Applicant Daig Corp.

K number K884494

View details →

DYB 1989-02-22

SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT

Applicant Mallinckroot, Inc.

K number K884159

View details →

DYB 1988-12-21

USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR

Applicant C.R. Bard, Inc.

K number K884104

View details →

DYB 1988-12-13

HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT

Applicant Harbor Medical Devices, Inc.

K number K882657

View details →

DYB 1988-12-02

INTRODUCING CATHETER

Applicant Devices For Vascular Intervention, Inc.

K number K883933

View details →

DYB 1988-09-28

MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH

Applicant Spectramed, Inc.

K number K881825

View details →

DYB 1988-08-12

OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE

Applicant Argon Medical Corp.

K number K882221

View details →

DYB 1988-05-31

ACS FUNNEL INTRODUCER

Applicant Advanced Cardiovascular Systems, Inc.

K number K875158

View details →

DYB 1988-02-29

OLYMPUS ANGIOSCOPY SHEATH

Applicant Olympus Corp.

K number K873100

View details →

DYB 1987-12-15

SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO

Applicant Angiomedics, Inc.

K number K873195

View details →

DYB 1987-10-07

PULL-APART INTRODUCER (SHEATH)

Applicant Quinton, Inc.

K number K873727

View details →

DYB 1987-09-30

OVAL PULL-APART SHEATH/DILATOR

Applicant Quinton, Inc.

K number K873394

View details →

DYB 1987-06-24

CATHETER INTRODUCER

Applicant Angeion Corp.

K number K871153

View details →

DYB 1987-06-05

UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M

Applicant Pacesetter Systems

K number K871208

View details →

DYB 1987-04-27

VASCATH VASCULAR CATHETER PLACEMENT KIT

Applicant Titan Medical, Inc.

K number K870542

View details →

DYB 1987-04-22

ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER

Applicant Aries Medical, Inc.

K number K871140

View details →

DYB 1987-04-20

PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS

Applicant Deltec Systems, Inc.

K number K871132

View details →

DYB 1987-04-09

INTRODUCER, PERCUTANEOUS

Applicant Med Fusion Systems, Inc.

K number K870907

View details →

DYB 1987-03-18

PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK

Applicant Daig Corp.

K number K870374

View details →

DYB 1987-03-16

ARIES TAPERED SHEATH

Applicant Aries Medical, Inc.

K number K870189

View details →

DYB 1987-02-13

MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH

Applicant Quinton, Inc.

K number K864705

View details →

DYB 1987-01-06

MODIFIED PEEL-AWAY INTRODUCER SET LINE

Applicant Quinton, Inc.

K number K864352

View details →

DYB 1987-01-06

CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.

Applicant Cardio-Vascular Innovations, Inc.

K number K863917

View details →

DYB 1986-10-10

TERUMO RADIFOCUS INTRODUCER KIT

Applicant Terumo Medical Corp.

K number K863139

View details →

DYB 1986-08-05

UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO

Applicant Universal Medical Instrument Corp.

K number K861984

View details →

DYB 1986-07-16

ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV

Applicant Angiomedics, Inc.

K number K861238

View details →

DYB 1986-06-19

MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER

Applicant Teleflex, Inc.

K number K861951

View details →

DYB 1986-05-20

PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET

Applicant Teleflex, Inc.

K number K860307

View details →

DYB 1986-05-05

CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST

Applicant Cordis Corp.

K number K861082

View details →

DYB 1986-04-29

SUBCLAVIAN INTRODUCER SET

Applicant Infusaid Corp.

K number K860898

View details →

DYB 1986-04-23

CATHETER INTRODUCER

Applicant Target Therapeutics

K number K860958

View details →

DYB 1986-04-16

CURITY PERCUTANEOUS CATHETER INSERTION KIT

Applicant The Kendal Co.

K number K855061

View details →

DYB 1986-04-16

CURITY PERCUTANEOUS CATHETER INSERTION TRAY

Applicant The Kendal Co.

K number K855060

View details →

DYB 1986-04-16

PMS PERCUTANEOUS PUNCTURE NEEDLE

Applicant Professional Medical Services

K number K854941

View details →

DYB 1986-03-31

PERCUTANEOUS INTRODUCER KIT

Applicant Cormed, Inc., Sub. C.R.Bard, Inc.

K number K860432

View details →

DYB 1986-03-31

VALVOKIT

Applicant Novamed Products, Inc.

K number K854831

View details →

DYB 1986-02-26

CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES

Applicant Cordis Corp.

K number K855126

View details →

DYB 1985-12-24

MEDTRONIC PERMANENT LEAD INTRODUCER

Applicant Medtronic Vascular

K number K854559

View details →

DYB 1985-12-09

CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90

Applicant Camino Laboratories, Inc.

K number K853072

View details →

DYB 1985-09-25

COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT

Applicant Cobe Laboratories, Inc.

K number K853100

View details →

DYB 1985-08-29

PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET)

Applicant Argon Medical Corp.

K number K852880

View details →

DYB 1985-08-16

PTCA GUIDING CATHETER

Applicant Cordis Corp.

K number K851947

View details →

DYB 1985-07-29

SLIM ART J. BIP PACING LEAD USING POLY #030-2821

Applicant Telectronics, Inc.

K number K852918

View details →

DYB 1985-07-29

SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283

Applicant Telectronics, Inc.

K number K852917

View details →

DYB 1985-07-29

SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284

Applicant Telectronics, Inc.

K number K852916

View details →

↑