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 1986-05-21

CARDIOPULMONARY CANNULA TUBING

Applicant Bio Medicus, Inc.

K number K861096

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DWF 1986-05-21

RMI CAROTID BY-PASS SHUNT

Applicant Research Medical, Inc.

K number K860988

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DWF 1986-03-31

VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015

Applicant Dlp, Inc.

K number K860149

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DWF 1986-02-10

MODIFIED CORONARY CARDIOPLEGIA ADAPTOR

Applicant Shiley, Inc.

K number K854640

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DWF 1986-02-10

VENOUS RETURN CANNULA W/CUFF 91039

Applicant Dlp, Inc.

K number K854487

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DWF 1985-10-17

SARNS EVACUPLEGE CATHETER

Applicant 3M Health Care, Sarns

K number K853128

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DWF 1985-10-11

SHILEY CSD EXTENSION LINE WITH FILTER

Applicant Shiley, Inc.

K number K852984

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DWF 1985-08-12

AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU

Applicant C.R. Bard, Inc.

K number K851323

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DWF 1985-06-11

DOSIMETRIC RELEASE OF RAD. TUBING PAC

Applicant American Bentley

K number K833047

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DWF 1985-05-21

BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER

Applicant American Bentley

K number K850925

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DWF 1985-05-21

ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN

Applicant Sherwood Medical Co.

K number K850917

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DWF 1985-04-29

INTRACARDIAC SUMP 12010

Applicant Dlp, Inc.

K number K850385

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DWF 1985-04-03

PUL,MONARY ARTERY VENT CATHETER

Applicant Dlp, Inc.

K number K845046

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DWF 1985-04-03

VENOUS RETURN CATHETER SS-1

Applicant Dlp, Inc.

K number K845045

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DWF 1985-02-27

PRUITT-VASCULAR SHUNTS

Applicant Ideas For Medicine, Inc.

K number K850356

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DWF 1984-12-27

STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH

Applicant Shiley, Inc.

K number K844140

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DWF 1984-12-27

STOCKERT-SHILEY INTRACARDIAC SUCKERS

Applicant Shiley, Inc.

K number K844139

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DWF 1984-12-27

STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI

Applicant Shiley, Inc.

K number K844138

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DWF 1984-12-27

STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN

Applicant Shiley, Inc.

K number K844137

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DWF 1984-10-18

SHILEY CORONARY CARDIOPLEGIA ADAPTOR

Applicant Shiley, Inc.

K number K843542

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DWF 1984-10-18

ARGYLE SILICONE LEFT VENTRICULAR AND

Applicant Sherwood Medical Co.

K number K843444

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DWF 1984-08-27

ARGYLE CUSTOM TUBING PACK

Applicant Sherwood Medical Co.

K number K842889

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DWF 1984-08-10

VENOUS CANNULA W/BENT, TIP WIRE

Applicant Dlp, Inc.

K number K842375

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DWF 1984-06-11

PRESSURE CATHETER PLACEMENT SET 50010

Applicant Dlp, Inc.

K number K841482

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DWF 1984-04-17

ARGYLE TAPERED VASCULAR SHUNT

Applicant Sherwood Medical Co.

K number K840914

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DWF 1984-04-17

SARNS 8.0 SOFT ARC CANNULA

Applicant 3M Health Care, Sarns

K number K834134

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DWF 1984-04-12

3-DAY BIOINDICATOR RELEASE PROCESS FOR

Applicant Shiley, Inc.

K number K833830

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DWF 1984-02-13

ARTERIAL CANNULA CURVED BEVELED TIP

Applicant Dlp, Inc.

K number K840002

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DWF 1984-02-13

ARTERIAL CANNULA STRAIGHT BEVELED TIP

Applicant Dlp, Inc.

K number K840001

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DWF 1984-01-03

INFANT VENT CATHETER 12001 W/SIDE VENT

Applicant Dlp, Inc.

K number K834039

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DWF 1984-01-03

SARNS CARDIOPLEGIA CANNULA Y

Applicant 3M Health Care, Sarns

K number K834025

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DWF 1983-11-28

TUBING FOR CARDIOPULMONARY BYPASS

Applicant Cardio Med Supplies, Inc.

K number K833112

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DWF 1983-10-19

AXIOM PERFUSSION CANNULA

Applicant Axiom Medical, Inc.

K number K832475

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DWF 1983-08-12

CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI

Applicant Med-West, Inc.

K number K832124

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DWF 1983-08-12

VARIOUS CARDIOVASCULAR SURGICAL DEVICE

Applicant Research Industries Corp.

K number K831769

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DWF 1983-08-12

INTRACARDIA SUCKERS

Applicant Research Industries Corp.

K number K831759

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DWF 1983-08-12

DISPOS. ABODOMINAL RETRACTING PAD

Applicant Product Development Corp.

K number K831130

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DWF 1983-08-10

UNIVERSAL CORONARY CANNULA

Applicant Possis Medical, Inc.

K number K831330

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DWF 1983-06-30

AORTIC ROOT CANNULA W/INTEGRAL PRESS

Applicant Dlp, Inc.

K number K831591

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DWF 1983-06-30

ARGYLE DUAL STAGE VENOUS RETURN CATH.

Applicant Sherwood Medical Co.

K number K831332

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DWF 1983-04-28

CARDIOVASCULAR DISPOSABLE PRODUCTS

Applicant Electromics, Inc.

K number K830728

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DWF 1982-08-31

ARGYLE CAROTID ARTERY LOOP SHUNT

Applicant Sherwood Medical Co.

K number K822317

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DWF 1982-08-24

SARNS CARDIOPLEGIA CANNULAE (VAR. TYPES

Applicant 3M Health Care, Sarns

K number K822210

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DWF 1982-08-06

KONTRON LITWAK-KOFFSKY OBTURATED CANNU

Applicant Kontron Instruments, Inc.

K number K821316

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DWF 1982-07-30

ARGYLE FERGUSON LEFT ATRIAL VENT CATH

Applicant Sherwood Medical Co.

K number K821445

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DWF 1982-05-18

SUBMISSION CORONARY CANNULA

Applicant Dlp, Inc.

K number K821149

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DWF 1981-12-14

FLOWGUARD CATHETERS & CANNALAE

Applicant Advocacy International, Ltd.

K number K813037

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DWF 1981-04-23

DISPOSABLE 2-STAGE CANNULA

Applicant Texas Medical Products, Inc.

K number K810515

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DWF 1981-04-03

CARDIOPULMONARY BYPASS

Applicant Dlp, Inc.

K number K810820

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DWF 1981-03-17

CARDIOPULMINARY BYPASS CATHETER CANNULA

Applicant Dlp, Inc.

K number K810548

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DWF 1981-03-17

SARNS TWO-STATE WIRE REINFORCED CATHETER

Applicant 3M Health Care, Sarns

K number K810415

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DWF 1981-01-16

RIDGID VENA CAVA CANNULAE

Applicant Texas Medical Products, Inc.

K number K802543

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DWF 1980-10-10

QUICK PRIME LINES, #'S BPL-12, BPL-48 &

Applicant Bentley Laboratories, Inc.

K number K802378

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DWF 1980-10-03

PRESSURE GAUGE ACCESSORY KIT/DILATATION

Applicant Stanco Medical, Inc.

K number K802261

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DWF 1980-08-07

ARTERIAL BUBBLE TRAP

Applicant Delta Medical Industries

K number K801770

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DWF 1980-07-28

PRUITT VASCULAR SHUNT

Applicant Ideas For Medicine, Inc.

K number K801359

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DWF 1980-06-30

DISPOSABLE PERFUSION SET

Applicant Texas Medical Products, Inc.

K number K801403

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DWF 1980-06-30

CARDIOPULMONARY BYPASS TUBING

Applicant Texas Medical Products, Inc.

K number K801401

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DWF 1980-06-30

AORTIC AND FEMORAL PERFUSION CANNULAE

Applicant Texas Medical Products, Inc.

K number K801398

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DWF 1980-06-30

VENA CAVA CANNULAE

Applicant Texas Medical Products, Inc.

K number K801397

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DWF 1980-06-30

SAPHENOUS VEIN CANNULAE

Applicant Texas Medical Products, Inc.

K number K801396

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DWF 1980-06-30

DISPOSABLE SUMP SETS

Applicant Texas Medical Products, Inc.

K number K801392

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DWF 1979-11-21

SARNS MEDIASTINAL AND PERICARDIAL TUBE

Applicant 3M Health Care, Sarns

K number K792070

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DWF 1979-11-20

TROCAR CATHETER/THORACIC CATHETER

Applicant Portex, Inc.

K number K792202

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DWF 1979-11-13

CARDIOPLEGIA SOLUTION ADMIN. SET

Applicant Cardio Systems, Inc.

K number K792152

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DWF 1979-11-13

SHILEY CARDIOPLEGIC SOLUTION DEL SETS

Applicant Shiley, Inc.

K number K791947

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DWF 1979-10-26

CARDIOPLEGIA ADMIN. SETS

Applicant Travenol Laboratories, S.A.

K number K791858

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DWF 1979-10-11

ARGYLE PEDIATRIC VENA CAVAL CATHETER

Applicant Sherwood Medical Co.

K number K791972

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DWF 1979-10-04

VEIN GRAFT CANNULA

Applicant D/P, Inc.

K number K791832

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DWF 1979-06-11

AORTIC ROOT CANNULA

Applicant Dlp, Inc.

K number K790565

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DWF 1979-03-02

SARNS WIRE-REINFORCED VENOUS RETURN CAN

Applicant 3M Health Care, Sarns

K number K790246

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DWF 1978-12-04

CARDIAC INSULATION PAD

Applicant Shiley, Inc.

K number K781990

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DWF 1977-10-04

TUBING SETS

Applicant Cobe Laboratories, Inc.

K number K771692

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DWF 1977-08-16

FLEXIBLE ARTERIAL CANNULAE

Applicant 3M Health Care, Sarns

K number K771499

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DWF 1977-03-16

CATHETER, TWO STAGE VENOUS RETURN

Applicant 3M Health Care, Sarns

K number K770431

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DWF 1977-03-16

CATHETER, CURVED LEFT HEART VENT

Applicant 3M Health Care, Sarns

K number K770430

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DWF 1977-03-16

CANNULAE, AORTIC, ARCH, HIGH FLOW

Applicant 3M Health Care, Sarns

K number K770429

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DWF 1977-03-01

CANNULA, HUNTER-SESSIONS, SELF-RETAIN.

Applicant Barlow Mfg., Corp.

K number K770068

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