Accessory Equipment, Cardiopulmonary Bypass

FDA product code KRI · 42 cleared devices

Class 1 Cardiovascular

Regulation: 21 CFR 870.4200
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-04-26 – 2002-05-03

KRI 2002-05-03

3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE

Applicant 3t Medical Systems, LLC

K number K020365

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KRI 1999-12-20

INTERFACE MODULE IDDD

Applicant Stoeckert Instrumente

K number K992635

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KRI 1999-11-23

STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS

Applicant Stoeckert Instrumente

K number K990512

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KRI 1993-11-18

AMMEX TUBING ORGANIZER

Applicant Ammex Cardiopulmonary Corp.

K number K934782

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KRI 1993-06-04

CARDIO2 CYCLE

Applicant Ergometrix, Inc.

K number K926233

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KRI 1992-11-23

TUBE GRIP

Applicant Georgia Medical Products, Inc.

K number K922404

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KRI 1989-11-08

NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS

Applicant Acacia Laboratories, Inc.

K number K892856

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KRI 1989-01-30

CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25

Applicant American Omni Medical, Inc.

K number K884893

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KRI 1989-01-24

CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700

Applicant American Omni Medical, Inc.

K number K884640

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KRI 1988-02-02

HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR

Applicant Mallinckrodt Critical Care

K number K874605

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KRI 1988-01-19

CPE 2000 CARDIO PULMONARY ERGOMETER

Applicant Medical Graphics Corp.

K number K874925

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KRI 1987-02-19

STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP

Applicant Shiley, Inc.

K number K864890

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KRI 1986-07-17

STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1

Applicant Shiley, Inc.

K number K862510

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KRI 1986-07-15

ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE

Applicant American Bentley

K number K862549

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KRI 1986-04-02

STABLELINE

Applicant Cardio Metrics, Inc.

K number K860298

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KRI 1986-03-03

ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL

Applicant American Bentley

K number K860672

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KRI 1986-01-08

CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH

Applicant American Bentley

K number K854113

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KRI 1985-09-16

GAMBRO DIGITAL TELETHERMOMETER TTH 10-200

Applicant Gambro, Inc.

K number K852455

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KRI 1985-07-11

CARDIAC COOLING JACKET

Applicant Pat O. Daily

K number K851077

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KRI 1985-06-19

COBE GAS FILTER

Applicant Cobe Laboratories, Inc.

K number K851289

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KRI 1984-06-11

HOLDER FOR BOS-10, 10S 5S

Applicant American Bentley

K number K841812

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KRI 1984-06-11

TUBE TENDER

Applicant The Anspach Effort, Inc.

K number K841296

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KRI 1984-04-17

HOLDER FOR MODELS AF-10,1025,1040,5

Applicant American Bentley

K number K841032

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KRI 1983-09-29

SHILEY GAS FILTER

Applicant Shiley, Inc.

K number K832704

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KRI 1983-09-12

GASLINE FILTER #GF-10

Applicant American Bentley

K number K832411

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KRI 1983-03-11

HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-

Applicant American Bentley

K number K830167

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KRI 1982-07-30

D645-BACTERIOLOGICAL GAS LINE FILTER

Applicant Electromedics, Inc.

K number K822097

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KRI 1982-03-02

TMO INTEGRATED CIRCUIT SYSTEM

Applicant Travenol Laboratories, S.A.

K number K820406

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KRI 1981-12-29

TEMPERATURE PROBES

Applicant Webster Laboratories, Inc.

K number K813271

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KRI 1981-06-09

CARDIOPLEGIA COOLING & ADMIN. SETS

Applicant Bentley Laboratories, Inc.

K number K811368

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KRI 1981-05-29

CARDIOPULMONARY BYPASS ACCESSORY EQUIP.

Applicant Bentley Laboratories, Inc.

K number K811348

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KRI 1981-01-30

SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS

Applicant 3M Health Care, Sarns

K number K810079

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KRI 1981-01-16

DISPOSABLE CONNECTORS

Applicant Texas Medical Products, Inc.

K number K802542

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KRI 1981-01-16

DISPOSABLE PARALLEL Y CONNECTORS

Applicant Texas Medical Products, Inc.

K number K802541

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KRI 1981-01-16

DISPOSABLE GAS LINE FILTER

Applicant Texas Medical Products, Inc.

K number K802539

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KRI 1980-12-16

WILLIAM HARVEY OXYGENATING GAS FILTER

Applicant C.R. Bard, Inc.

K number K802906

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KRI 1979-11-13

OXYGENATOR GAS LINE FILTER

Applicant Cardio Systems, Inc.

K number K792151

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KRI 1979-10-02

SHILEY QUICK DISCONNECT ASSEMBLY

Applicant Shiley, Inc.

K number K791829

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KRI 1979-02-08

SARNO SINGLE POLE MAST

Applicant Sames, Inc.

K number K790192

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KRI 1978-11-15

FILTER, EXTRACORPOREAL BLOOD HOLDER

Applicant Surgikos, Inc.

K number K781861

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KRI 1978-07-17

PVC QUICK PRIME LINES

Applicant Norton Performance Plastics Corp.

K number K780984

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KRI 1977-04-26

VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR

Applicant Scimed Life Systems, Inc.

K number K770681

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