Heat-Exchanger, Cardiopulmonary Bypass

FDA product code DTR · 91 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.4240
Review panel: CV
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1977-01-14 – 2026-03-12

DTR 2026-03-12

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

Applicant Spectrum Medical S.R.L.

K number K252541

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DTR 2025-07-08

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)

Applicant Spectrum Medical , Ltd.

K number K240908

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DTR 2025-05-30

VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)

Applicant Sorin Group Italia S.R.L.

K number K250150

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DTR 2024-02-23

MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated

Applicant Medtronic

K number K240190

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DTR 2023-04-13

Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)

Applicant Quara S.R.L.

K number K223879

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DTR 2022-05-06

Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger

Applicant Qura S.R.L

K number K220110

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DTR 2022-01-10

Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger

Applicant Qura S.R.L

K number K212688

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DTR 2020-11-20

MPS 3 ND Myocardial Protection System

Applicant Quest Medical, Inc.

K number K201984

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DTR 2020-06-19

MPS 3 Myocardial Protection System

Applicant Quest Medical, Inc.

K number K200438

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DTR 2018-10-01

MPS2 Myocardial Protection System Console

Applicant Quest Medical, Inc.

K number K173716

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DTR 2017-02-10

MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)

Applicant Medtronic, Inc.

K number K162774

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DTR 2017-02-01

MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge

Applicant Medtronic, Inc.

K number K162958

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DTR 2009-12-23

PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30

Applicant Maquet Cardiopulmonary, AG

K number K090555

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DTR 2009-01-26

GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING

Applicant Gish Biomedical, Inc.

K number K081838

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DTR 2008-04-04

PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30

Applicant Maquet Cardiopulmonary, AG

K number K072583

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DTR 2004-09-02

MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260

Applicant Quest Medical, Inc.

K number K041979

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DTR 2004-03-15

VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING

Applicant Gish Biomedical, Inc.

K number K040355

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DTR 2003-08-22

CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200

Applicant Cardiovention, Inc.

K number K032068

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DTR 2002-07-02

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

Applicant Cobe Cardiovascular, Inc.

K number K021830

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DTR 2002-04-10

VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER

Applicant Gish Biomedical, Inc.

K number K020106

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DTR 2001-09-17

MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM

Applicant Cobe Cardiovascular, Inc.

K number K012898

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DTR 2001-03-23

COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS

Applicant Olson Medical Sales, Inc.

K number K000977

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DTR 2000-12-21

CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B

Applicant Medtronic Vascular

K number K003724

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DTR 2000-06-08

ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER

Applicant Minntech Corp.

K number K991137

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DTR 1999-06-23

CAPIOX CARDIOPLEGIA

Applicant Terumo Medical Corp.

K number K982467

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DTR 1997-11-20

CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)

Applicant Medtronic Vascular

K number K973475

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DTR 1997-08-08

VISION CARDIOPLEGIA DELIVERY SYSTEM

Applicant Lifestream Int'L, Inc.

K number K964571

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DTR 1997-01-10

S3 CARDIOPLEGIA CONTROL

Applicant Stoeckert Instrumente

K number K962320

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DTR 1996-03-06

MYOCARDIAL PROTECTION SYSTEM

Applicant Quest Medical, Inc.

K number K953838

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DTR 1995-06-30

SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS

Applicant Gish Biomedical, Inc.

K number K944219

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DTR 1995-04-28

HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA

Applicant Cobe Cardiovascular, Inc.

K number K944267

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DTR 1993-12-03

ELECTROMEDICS BLOOD HEAT EXCHANGER

Applicant Electromedics, Inc.

K number K934355

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DTR 1993-08-05

ROTATOR;MALE-MALE, MALE-FEMALE

Applicant Merit Medical Systems, Inc.

K number K932251

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DTR 1993-07-13

HE-30 GOLD

Applicant Bentley Laboratories, Inc.

K number K931967

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DTR 1993-03-26

BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS

Applicant Sorin Biomedica, Fiat, USA, Inc.

K number K925369

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DTR 1992-09-18

CONDUCER HEAT EXCHANGER

Applicant 3M Health Care, Sarns

K number K923311

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DTR 1992-01-09

LANCASTER COOLING JACKET, CAT. CODE #13500/13501

Applicant Dlp, Inc.

K number K913077

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DTR 1991-12-18

CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES

Applicant Gish Biomedical, Inc.

K number K913691

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DTR 1991-12-04

MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF

Applicant Medtronic Vascular

K number K914742

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DTR 1991-06-10

MYOCARDIAL PROTECTION SYSTEM

Applicant Medtronic Vascular

K number K905500

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DTR 1991-04-09

BCD ADVANCED

Applicant Shiley, Inc.

K number K910923

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DTR 1991-01-23

TOPICAL COOLING PAD, MODEL 7000

Applicant Daily Medical Products, Inc.

K number K905568

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DTR 1990-12-06

SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM

Applicant Scimed

K number K904171

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DTR 1990-07-31

SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM

Applicant Gish Biomedical, Inc.

K number K896807

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DTR 1990-05-17

EXTRACORPOREAL HEAT EXCHANGER HE SERIES

Applicant Gish Biomedical, Inc.

K number K896020

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DTR 1990-04-20

MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU

Applicant 3M Company

K number K900640

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DTR 1990-03-16

SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)

Applicant 3M Company

K number K897039

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DTR 1989-04-03

SCIMED ECMOTHERM(TM) HEAT EXCHANGER

Applicant Scimed Life Systems, Inc.

K number K884560

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DTR 1988-12-05

SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM

Applicant 3M Health Care, Sarns

K number K883071

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DTR 1988-10-13

INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM

Applicant Medtronic Blood Systems, Inc.

K number K883439

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DTR 1988-09-26

MAST FOR BASIC HEATER-COOLER UNIT 16-09-00

Applicant Shiley, Inc.

K number K883332

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DTR 1988-09-26

BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10

Applicant Shiley, Inc.

K number K883331

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DTR 1988-09-26

BASIC HEATER-COOLER UNIT, 115/100V 16-02-20

Applicant Shiley, Inc.

K number K883330

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DTR 1988-05-11

SHILEY BCD PLUS HEAT EXCHANGER

Applicant Shiley, Inc.

K number K880663

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DTR 1988-04-28

SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS

Applicant Scimed Life Systems, Inc.

K number K880451

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DTR 1987-11-05

ELECTROMEDICS D1079E

Applicant Electromedics, Inc.

K number K873561

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DTR 1987-09-01

CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100

Applicant American Bentley

K number K870804

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DTR 1987-08-03

CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS

Applicant Gish Biomedical, Inc.

K number K871774

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DTR 1986-05-28

CPS-3000 CARDIOPLEGIA RESERVOIR

Applicant Gish Biomedical, Inc.

K number K861102

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DTR 1986-05-21

STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL

Applicant Shiley, Inc.

K number K860920

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DTR 1986-04-29

CARDIO-COOL

Applicant Bio-Vascular, Inc.

K number K860523

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DTR 1985-12-09

NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000

Applicant Norton Performance Plastics Corp.

K number K853791

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DTR 1985-11-14

SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM

Applicant 3M Health Care, Sarns

K number K853516

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DTR 1985-10-11

MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K853410

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DTR 1985-09-30

BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)

Applicant Shiley, Inc.

K number K852780

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DTR 1985-04-18

PATIENT MONITOR MODEL RM-300

Applicant Honeywell, Inc.

K number K850794

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DTR 1984-12-27

MYOCARDIAL INSULATOR

Applicant Norton Texas Medical Products

K number K843983

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DTR 1984-02-17

CARDIOPLEGIA HEAT EXCHANGER HOLDER

Applicant American Bentley

K number K840256

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DTR 1984-02-13

CARDIOPLEGIA HEAT EXCHANGER HE-100

Applicant American Bentley

K number K840045

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DTR 1984-02-04

LAL TEST RELEASE & BONCHEK CAR/JACKET

Applicant Shiley, Inc.

K number K833555

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DTR 1983-12-29

CARDIOPLEGIA SYSTEM CCS-XXX SERIES

Applicant Gish Biomedical, Inc.

K number K833662

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DTR 1983-10-20

HYPOTHERMIC MYCARDIAL PROTECTION DEV

Applicant 3M Health Care, Sarns

K number K832417

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DTR 1983-05-09

BLOOD CARDIOPLEGIA STAINLESS STEEL COOL

Applicant American Bentley

K number K831157

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DTR 1983-01-14

CLEAR CARDIOPLEJIA DELIVERY SYSTEM

Applicant 3M Health Care, Sarns

K number K823451

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DTR 1982-12-30

JACKET & SET

Applicant Shiley, Inc.

K number K823533

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DTR 1982-07-06

D6ZO DISPOSABLE HEAT EXCHANGER

Applicant Electromedics, Inc.

K number K813264

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DTR 1981-08-13

COBE HEAT EXCHANGER RESERVOIR MODULE

Applicant Cobe Laboratories, Inc.

K number K812093

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DTR 1981-05-21

BRONCHEK-SHILEY CARDIAC JACKET & BSC J

Applicant Shiley, Inc.

K number K811204

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DTR 1981-01-16

CARDIOPLEGIC SETS

Applicant Texas Medical Products, Inc.

K number K802545

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DTR 1980-12-19

BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.

Applicant Shiley, Inc.

K number K802879

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DTR 1980-12-11

CARDIOPLEGIA COOLING SYST. CCAS-2

Applicant Bentley Laboratories, Inc.

K number K802848

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DTR 1980-04-16

TOPICAL COOLING DEV. TCD. #27-999

Applicant Cobe Laboratories, Inc.

K number K800717

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DTR 1980-03-19

CARDIOPLEGIA DELIVERY SYSTEM

Applicant 3M Health Care, Sarns

K number K800377

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DTR 1979-08-28

MINIPRIME HYPOTHERMIC HEAT EXCHANGER

Applicant Travenol Laboratories, S.A.

K number K791430

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DTR 1979-06-11

HEAT EXCHANGER COIL

Applicant Delta Medical Industries

K number K790756

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DTR 1978-12-04

PAD, COOLING #27-999

Applicant Cobe Laboratories, Inc.

K number K781764

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DTR 1978-10-10

HEAT EXCHANGER, FHX-14

Applicant Delta Medical Industries

K number K781210

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DTR 1978-03-02

HEAT EXCHANGER, DISP., OMNITHERM

Applicant Scimed Life Systems, Inc.

K number K772117

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DTR 1977-01-14

PACING KIT, SEMI-FLOATING

Applicant Electro-Catheter Corp.

K number K770018

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DTR 1977-01-14

PACING KIT, TRANSMYOCARDIAL

Applicant Electro-Catheter Corp.

K number K770017

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DTR 1977-01-14

PACING KIT, ELECATH TRANSTHORACIC

Applicant Electro-Catheter Corp.

K number K770016

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