ClearanceBrief
Panels › Cardiovascular › Product code DTR · Class 2

Heat-Exchanger, Cardiopulmonary Bypass

Regulation 870.4240

1510(k)s in 12 months (91 all time)
2recalls in 12 months (35 all time)
27recalls that name a 510(k)
Get daily alerts for DTRSample briefCSV

Top companies in DTR

Company510(k)sRecalls
Terumo Cardiovascular Systems Corp020
Shiley, Inc.110
Gish Biomedical, Inc.100
Quest Medical, Inc.53
Terumo Cardiovascular Corporation08
3M Health Care, Sarns60
American Bentley40
Medtronic Vascular40
Cobe Cardiovascular, Inc.30
Cobe Laboratories, Inc.30
Decided510(k)Device and applicantCode
Mar 12, 2026K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
Spectrum Medical S.R.L., IT
DTR
Jul 8, 2025K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
Spectrum Medical , Ltd., GB
DTR
May 30, 2025K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard
Sorin Group Italia S.R.L., IT
DTR
Feb 23, 2024K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoat
Medtronic
DTR
Apr 13, 2023K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
Quara S.R.L., IT
DTR
May 6, 2022K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
Qura S.R.L, IT
DTR
Jan 10, 2022K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
Qura S.R.L, IT
DTR
Nov 20, 2020K201984MPS 3 ND Myocardial Protection System
Quest Medical, Inc.
DTR
Jun 19, 2020K200438MPS 3 Myocardial Protection System
Quest Medical, Inc.
DTR
Oct 1, 2018K173716MPS2 Myocardial Protection System Console
Quest Medical, Inc.
DTR
Feb 10, 2017K162774MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with C
Medtronic, Inc.
DTR
Feb 1, 2017K162958MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trilliu
Medtronic, Inc.
DTR
Dec 23, 2009K090555PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
Maquet Cardiopulmonary, AG, DE
DTR
Jan 26, 2009K081838GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
Gish Biomedical, Inc.
DTR
Apr 4, 2008K072583PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
Maquet Cardiopulmonary, AG, DE
DTR
Sep 2, 2004K041979MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
Quest Medical, Inc.
DTR
Mar 15, 2004K040355VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING
Gish Biomedical, Inc.
DTR
Aug 22, 2003K032068CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
Cardiovention, Inc.
DTR
Jul 2, 2002K021830SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
Cobe Cardiovascular, Inc.
DTR
Apr 10, 2002K020106VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
Gish Biomedical, Inc.
DTR
Sep 17, 2001K012898MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
Cobe Cardiovascular, Inc.
DTR
Mar 23, 2001K000977COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
Olson Medical Sales, Inc.
DTR
Dec 21, 2000K003724CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
Medtronic Vascular
DTR
Jun 8, 2000K991137ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
Minntech Corp.
DTR
Jun 23, 1999K982467CAPIOX CARDIOPLEGIA
Terumo Medical Corp.
DTR
Nov 20, 1997K973475CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
Medtronic Vascular
DTR
Aug 8, 1997K964571VISION CARDIOPLEGIA DELIVERY SYSTEM
Lifestream Int'L, Inc.
DTR
Jan 10, 1997K962320S3 CARDIOPLEGIA CONTROL
Stoeckert Instrumente
DTR
Mar 6, 1996K953838MYOCARDIAL PROTECTION SYSTEM
Quest Medical, Inc.
DTR
Jun 30, 1995K944219SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS
Gish Biomedical, Inc.
DTR
Apr 28, 1995K944267HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
Cobe Cardiovascular, Inc.
DTR
Dec 3, 1993K934355ELECTROMEDICS BLOOD HEAT EXCHANGER
Electromedics, Inc.
DTR
Aug 5, 1993K932251ROTATOR;MALE-MALE, MALE-FEMALE
Merit Medical Systems, Inc.
DTR
Jul 13, 1993K931967HE-30 GOLD
Bentley Laboratories, Inc.
DTR
Mar 26, 1993K925369BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
Sorin Biomedica, Fiat, USA, Inc.
DTR
Sep 18, 1992K923311CONDUCER HEAT EXCHANGER
3M Health Care, Sarns
DTR
Jan 9, 1992K913077LANCASTER COOLING JACKET, CAT. CODE #13500/13501
Dlp, Inc.
DTR
Dec 18, 1991K913691CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES
Gish Biomedical, Inc.
DTR
Dec 4, 1991K914742MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF
Medtronic Vascular
DTR
Jun 10, 1991K905500MYOCARDIAL PROTECTION SYSTEM
Medtronic Vascular
DTR
Apr 9, 1991K910923BCD ADVANCED
Shiley, Inc.
DTR
Jan 23, 1991K905568TOPICAL COOLING PAD, MODEL 7000
Daily Medical Products, Inc.
DTR
Dec 6, 1990K904171SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM
Scimed
DTR
Jul 31, 1990K896807SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
Gish Biomedical, Inc.
DTR
May 17, 1990K896020EXTRACORPOREAL HEAT EXCHANGER HE SERIES
Gish Biomedical, Inc.
DTR
Apr 20, 1990K900640MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
3M Company
DTR
Mar 16, 1990K897039SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)
3M Company
DTR
Apr 3, 1989K884560SCIMED ECMOTHERM(TM) HEAT EXCHANGER
Scimed Life Systems, Inc.
DTR
Dec 5, 1988K883071SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM
3M Health Care, Sarns
DTR
Oct 13, 1988K883439INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM
Medtronic Blood Systems, Inc.
DTR

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.