Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

FDA product code DWF · 378 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.4210
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-03-01 – 2026-04-23

DWF 1996-03-26

FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER

Applicant Quest Medical, Inc.

K number K955818

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DWF 1996-03-26

RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET

Applicant Dlp, Inc.

K number K953945

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DWF 1995-06-14

QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS

Applicant Quest Medical, Inc.

K number K951088

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DWF 1995-06-02

AORTIC ARCH CANNULAS

Applicant Sorin Group Italia S.R.L.

K number K943934

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DWF 1995-05-25

QUEST ANTEGRADE CARDIOPLEGIA CANNULA

Applicant Quest Medical, Inc.

K number K950814

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DWF 1995-04-06

QUEST CORONARY SINUS PERFUSION CANNULA -FRCC

Applicant Quest Medical, Inc.

K number K941916

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DWF 1995-01-17

QUEST CORONARY SINUS PERFUSION CANNULA

Applicant Quest Medical, Inc.

K number K941166

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DWF 1994-08-09

EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM

Applicant Baxter Healthcare Corp

K number K932208

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DWF 1994-02-22

SARNS LOW JETTING AORTIC ARCH CANNULA

Applicant 3M Health Care, Sarns

K number K934127

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DWF 1994-02-01

QUEST HEART INSULATION PAD

Applicant Quest Medical, Inc.

K number K925049

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DWF 1993-09-27

VITAL-PORT MINI VASCULAR ACCESS SYSTEM

Applicant Med Institute, Inc.

K number K931586

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DWF 1993-06-23

SIGNATURE(TM) CUSTOM TUBING PACK

Applicant Avecor Cardiovascular, Inc.

K number K924529

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DWF 1993-05-21

SARNS RETROGRADE CANNULA

Applicant 3M Health Care, Sarns

K number K925442

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DWF 1993-05-11

BARD WILLIAM HARVEY TWO STAGE CANNULA

Applicant C.R. Bard, Inc.

K number K930684

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DWF 1993-05-11

MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA

Applicant 3M Health Care, Sarns

K number K920902

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DWF 1993-05-07

BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA

Applicant C.R. Bard, Inc.

K number K930620

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DWF 1993-05-06

BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU

Applicant C.R. Bard, Inc.

K number K930593

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DWF 1993-03-26

MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER

Applicant Medtronic Bio-Medicus, Inc.

K number K924642

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DWF 1993-03-22

BARD WILLIAM HARVEY AORTIC ARCH CANULAE

Applicant C.R. Bard, Inc.

K number K923483

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DWF 1993-03-12

SARNS RETROGRADE CANNULA - AUTO INFLATE

Applicant 3M Health Care, Sarns

K number K922471

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DWF 1992-12-08

MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT

Applicant Medtronic Bio-Medicus, Inc.

K number K924643

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DWF 1992-09-18

CONDUCER CARDIOPLEGIA SET SITH MP4

Applicant 3M Health Care, Ltd.

K number K922992

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DWF 1992-07-27

CATHETER TWO STAGE VENOUS RETURN

Applicant Dlp, Inc.

K number K915268

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DWF 1992-03-04

SARNS RETROGRADE CANNULA

Applicant 3M Health Care, Sarns

K number K915193

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DWF 1991-09-19

FURUI SHUNT, 2-WAY AND 3-WAY

Applicant Theramed, Inc.

K number K910004

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DWF 1991-05-22

CARDIOPULMONARY BYPASS PUMP TUBING

Applicant Jtl Medical Corp.

K number K910021

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DWF 1991-02-05

CARDIOPULMONARY BYPASS VASCULAR CATHETER

Applicant 3M Health Care, Sarns

K number K905224

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DWF 1991-02-01

SARNS INVENT CATHETERS

Applicant 3M Health Care, Sarns

K number K905638

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DWF 1991-01-15

DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS

Applicant Baxter Bentley Laboratories, Inc.

K number K905312

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DWF 1990-09-27

RESUBMITTED MULTIORGAN PERFUSION CANNULA

Applicant Fresenius USA, Inc.

K number K902394

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DWF 1990-08-14

BARD EXTRACORPOREAL CIRCULATION CANNULAE

Applicant C.R. Bard, Inc.

K number K902277

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DWF 1990-07-06

CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA

Applicant Dlp, Inc.

K number K901074

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DWF 1990-06-08

RMI CARDIOPLEGIA DELIVERY KITS

Applicant Research Medical, Inc.

K number K901231

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DWF 1990-05-17

VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA

Applicant Voss Medical Products

K number K896338

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DWF 1990-04-10

SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)

Applicant Shiley, Inc.

K number K900753

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DWF 1990-03-16

PICSO CANNULA, CATALOG CODE 94315

Applicant Dlp, Inc.

K number K897022

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DWF 1990-02-27

RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE

Applicant Research Medical, Inc.

K number K896778

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DWF 1990-02-27

RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE

Applicant Research Medical, Inc.

K number K896777

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DWF 1990-02-26

CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.

Applicant Canyon Medical Products

K number K897026

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DWF 1990-02-15

RMI ANTEPLEGIA CANNULA

Applicant Research Medical, Inc.

K number K896636

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DWF 1989-11-29

KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K895352

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DWF 1989-10-17

PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT

Applicant Pioneering Technologies, Inc.

K number K894684

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DWF 1989-10-12

FEM-FLEX FEMORAL ACCESS CANNULATION SET

Applicant Research Medical, Inc.

K number K891576

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DWF 1989-05-01

MODIFIED STOCKERT-SHILEY VENOUS CATHETER

Applicant Shiley, Inc.

K number K890980

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DWF 1989-03-02

SARNS VENT CATHETER

Applicant 3M Company

K number K890024

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DWF 1989-02-08

THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)

Applicant Promedica Products, Inc.

K number K883412

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DWF 1989-02-06

MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY

Applicant Quinton, Inc.

K number K885188

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DWF 1989-01-10

ANGIOPUMP TUBING SET

Applicant Olympus Corp.

K number K884310

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DWF 1988-12-27

MODIFIED SHILEY FEMORAL ARTERIAL CANNULA

Applicant Shiley, Inc.

K number K884393

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DWF 1988-11-03

GUIDING CATHETER (TIP SOFTNESS CHANGE)

Applicant Devices For Vascular Intervention, Inc.

K number K883981

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DWF 1988-10-13

PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT

Applicant Pioneering Technologies, Inc.

K number K883221

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DWF 1988-09-27

EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER

Applicant Cook, Inc.

K number K882771

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DWF 1988-07-28

INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER

Applicant Buckman Co., Inc.

K number K882034

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DWF 1988-07-06

SHILEY FEMORAL CORONARY PERFUSION CATHETER

Applicant Shiley, Inc.

K number K881733

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DWF 1988-07-05

SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER

Applicant Shiley, Inc.

K number K881734

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DWF 1988-07-05

PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA

Applicant Shiley, Inc.

K number K881691

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DWF 1988-06-10

COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK

Applicant Cobe Laboratories, Inc.

K number K881330

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DWF 1988-06-09

RIGHT ATRIAL CATHETER INSERTION TRAY

Applicant Quinton, Inc.

K number K881352

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DWF 1988-05-31

SHILEY FEMORAL VENOUS CANNULA

Applicant Shiley, Inc.

K number K881074

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DWF 1988-05-31

SHILEY FEMORAL ARTERIAL CANNULA

Applicant Shiley, Inc.

K number K881072

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DWF 1988-05-24

NEOCATH

Applicant Taris Corp.

K number K880887

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DWF 1988-05-24

8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM

Applicant Medsurg Industries, Inc.

K number K880777

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DWF 1988-05-09

MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY

Applicant Medsurg Industries, Inc.

K number K880779

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DWF 1988-04-28

DESCENDING ARCH CANNULA

Applicant Dlp, Inc.

K number K880421

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DWF 1988-03-22

STATFLO

Applicant Imodex, Inc.

K number K880180

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DWF 1988-03-22

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL.

Applicant Research Medical, Inc.

K number K880103

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DWF 1988-03-22

PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT

Applicant Dlp, Inc.

K number K875353

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DWF 1988-02-18

SARNS VENOATRIAL CATHETER

Applicant 3M Health Care, Sarns

K number K875048

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DWF 1988-02-18

CANYON MEDICAL FEMORAL BYPASS CANNULAE

Applicant Canyon Medical Products

K number K874899

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DWF 1988-02-05

POLYSTAN TWO STAGE CATHETERS

Applicant Polystan C/O Vitalcor, Inc.

K number K874853

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DWF 1988-02-05

POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS

Applicant Polystan C/O Vitalcor, Inc.

K number K874852

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DWF 1988-02-02

SARNS VISIFLOW AORTIC ARCH CANNULA

Applicant 3M Health Care, Sarns

K number K874896

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DWF 1988-01-19

ARGYLE CARDIOPLEGIA CANNULA

Applicant Sherwood Medical Co.

K number K874834

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DWF 1987-12-07

BIO-MEDICUS CANNULA-TUBING

Applicant Bio Medicus, Inc.

K number K872033

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DWF 1987-11-06

SARNS CARDIOPLEGIA/VENT CATHETERS

Applicant 3M Health Care, Sarns

K number K873212

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DWF 1987-09-30

CHURCHILL INTER-CARDIAC SUCKER

Applicant Churchill Corp.

K number K872043

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DWF 1987-09-25

MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN

Applicant Uresil Corp.

K number K872788

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DWF 1987-09-24

TORAY ANTHRON AORTA BYPASS TUBES

Applicant Toray Industries (America), Inc.

K number K872762

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DWF 1987-08-12

DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES

Applicant Shiley, Inc.

K number K872159

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DWF 1987-08-03

ARGYLE VASCULAR BYPASS SET

Applicant Sherwood Medical Co.

K number K871844

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DWF 1987-06-08

BUBBLE TRAP CAT. NO. B-180

Applicant American Omni Medical, Inc.

K number K870819

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DWF 1987-05-22

TDMAC-HEPARIN COATED RMI

Applicant Research Medical, Inc.

K number K870421

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DWF 1987-03-16

GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA

Applicant Research Medical, Inc.

K number K870507

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DWF 1987-03-16

RMI VENOUS DRAINAGE CANNULA

Applicant Research Medical, Inc.

K number K870109

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DWF 1987-03-03

ASPIRATING NEEDLE, CATALOG CODE #12006

Applicant Dlp, Inc.

K number K865079

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DWF 1987-03-03

SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER

Applicant Angiomedics, Inc.

K number K863342

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DWF 1987-02-19

RMI FEMORAL VENOUS DRAINAGE CANNULA

Applicant Research Medical, Inc.

K number K863740

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DWF 1986-11-24

URESIL CAROTID SHUNT

Applicant Uresil Corp.

K number K863558

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DWF 1986-11-03

WALRUS: DOUBLE BALLOON SHUNTING CATHETER

Applicant Medical Parameters, Inc.

K number K862190

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DWF 1986-10-31

TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT

Applicant Research Medical, Inc.

K number K862634

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DWF 1986-07-21

RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT

Applicant Research Medical, Inc.

K number K861790

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DWF 1986-06-25

BARD-PARKER CAROTID SHUNT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K860136

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DWF 1986-05-30

RMI POROUS VENT PLUG

Applicant Research Medical, Inc.

K number K861322

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DWF 1986-05-30

STOCKERT-SHILEY AORTIC ROOT CANNULAE

Applicant Shiley, Inc.

K number K861310

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DWF 1986-05-28

TORAY ANTHRON BYPASS TUBES

Applicant Toray Industries (America), Inc.

K number K861116

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DWF 1986-05-28

CHEST DRAINAGE PACK, CDP-1000

Applicant Gish Biomedical, Inc.

K number K861103

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DWF 1986-05-28

CAROTID BYPASS SHUNT WITH SAMPLING ARM

Applicant Clincal Instruments Corp.

K number K860743

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DWF 1986-05-28

CAROTID BYPASS SHUNT

Applicant Clincal Instruments Corp.

K number K860742

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DWF 1986-05-28

CAROTID BALLOON SHUNT

Applicant Imodex, Inc.

K number K860497

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DWF 1986-05-27

STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA

Applicant Shiley, Inc.

K number K861496

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