FDA Product Code
FDA Product Code DTR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4240
510(k) Clearances — 91 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | 2026-03-12 | Traditional | PDF ↗ |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | Spectrum Medical , Ltd. | 2025-07-08 | Traditional | PDF ↗ |
| K250150 | 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) | Sorin Group Italia S.R.L. | 2025-05-30 | Special | PDF ↗ |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | Medtronic | 2024-02-23 | Special | PDF ↗ |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | Quara S.R.L. | 2023-04-13 | Special | PDF ↗ |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | 2022-05-06 | Traditional | PDF ↗ |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | 2022-01-10 | Traditional | PDF ↗ |
| K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | 2020-11-20 | Traditional | PDF ↗ |
| K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020-06-19 | Traditional | PDF ↗ |
| K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | 2018-10-01 | Traditional | PDF ↗ |
| K162774 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) | Medtronic, Inc. | 2017-02-10 | Traditional | PDF ↗ |
| K162958 | 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 | Medtronic, Inc. | 2017-02-01 | Traditional | PDF ↗ |
| K090555 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 | Maquet Cardiopulmonary, AG | 2009-12-23 | Special | PDF ↗ |
| K081838 | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | Gish Biomedical, Inc. | 2009-01-26 | Traditional | PDF ↗ |
| K072583 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 | Maquet Cardiopulmonary, AG | 2008-04-04 | Traditional | PDF ↗ |
| K041979 | MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 | Quest Medical, Inc. | 2004-09-02 | Special | PDF ↗ |
| K040355 | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING | Gish Biomedical, Inc. | 2004-03-15 | Traditional | PDF ↗ |
| K032068 | CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 | Cardiovention, Inc. | 2003-08-22 | Traditional | PDF ↗ |
| K021830 | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM | Cobe Cardiovascular, Inc. | 2002-07-02 | Special | PDF ↗ |
| K020106 | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER | Gish Biomedical, Inc. | 2002-04-10 | Traditional | PDF ↗ |
| K012898 | MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM | Cobe Cardiovascular, Inc. | 2001-09-17 | Special | PDF ↗ |
| K000977 | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS | Olson Medical Sales, Inc. | 2001-03-23 | Traditional | PDF ↗ |
| K003724 | CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B | Medtronic Vascular | 2000-12-21 | Special | PDF ↗ |
| K991137 | ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER | Minntech Corp. | 2000-06-08 | Traditional | PDF ↗ |
| K982467 | CAPIOX CARDIOPLEGIA | Terumo Medical Corp. | 1999-06-23 | Traditional | PDF ↗ |
| K973475 | CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) | Medtronic Vascular | 1997-11-20 | Traditional | PDF ↗ |
| K964571 | VISION CARDIOPLEGIA DELIVERY SYSTEM | Lifestream Int'L, Inc. | 1997-08-08 | Traditional | PDF ↗ |
| K962320 | S3 CARDIOPLEGIA CONTROL | Stoeckert Instrumente | 1997-01-10 | Traditional | PDF ↗ |
| K953838 | MYOCARDIAL PROTECTION SYSTEM | Quest Medical, Inc. | 1996-03-06 | Traditional | PDF ↗ |
| K944219 | SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS | Gish Biomedical, Inc. | 1995-06-30 | Traditional | PDF ↗ |
| K944267 | HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA | Cobe Cardiovascular, Inc. | 1995-04-28 | Traditional | PDF ↗ |
| K934355 | ELECTROMEDICS BLOOD HEAT EXCHANGER | Electromedics, Inc. | 1993-12-03 | Traditional | PDF ↗ |
| K932251 | ROTATOR;MALE-MALE, MALE-FEMALE | Merit Medical Systems, Inc. | 1993-08-05 | Traditional | PDF ↗ |
| K931967 | HE-30 GOLD | Bentley Laboratories, Inc. | 1993-07-13 | Traditional | PDF ↗ |
| K925369 | BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS | Sorin Biomedica, Fiat, USA, Inc. | 1993-03-26 | Traditional | PDF ↗ |
| K923311 | CONDUCER HEAT EXCHANGER | 3M Health Care, Sarns | 1992-09-18 | Traditional | PDF ↗ |
| K913077 | LANCASTER COOLING JACKET, CAT. CODE #13500/13501 | Dlp, Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K913691 | CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES | Gish Biomedical, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K914742 | MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF | Medtronic Vascular | 1991-12-04 | Traditional | PDF ↗ |
| K905500 | MYOCARDIAL PROTECTION SYSTEM | Medtronic Vascular | 1991-06-10 | Traditional | PDF ↗ |
| K910923 | BCD ADVANCED | Shiley, Inc. | 1991-04-09 | Traditional | PDF ↗ |
| K905568 | TOPICAL COOLING PAD, MODEL 7000 | Daily Medical Products, Inc. | 1991-01-23 | Traditional | PDF ↗ |
| K904171 | SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM | Scimed | 1990-12-06 | Traditional | PDF ↗ |
| K896807 | SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM | Gish Biomedical, Inc. | 1990-07-31 | Traditional | PDF ↗ |
| K896020 | EXTRACORPOREAL HEAT EXCHANGER HE SERIES | Gish Biomedical, Inc. | 1990-05-17 | Traditional | PDF ↗ |
| K900640 | MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU | 3M Company | 1990-04-20 | Traditional | PDF ↗ |
| K897039 | SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM) | 3M Company | 1990-03-16 | Traditional | PDF ↗ |
| K884560 | SCIMED ECMOTHERM(TM) HEAT EXCHANGER | Scimed Life Systems, Inc. | 1989-04-03 | Traditional | PDF ↗ |
| K883071 | SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM | 3M Health Care, Sarns | 1988-12-05 | Traditional | PDF ↗ |
| K883439 | INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM | Medtronic Blood Systems, Inc. | 1988-10-13 | Traditional | PDF ↗ |
| K883330 | BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 | Shiley, Inc. | 1988-09-26 | Traditional | PDF ↗ |
| K883331 | BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10 | Shiley, Inc. | 1988-09-26 | Traditional | PDF ↗ |
| K883332 | MAST FOR BASIC HEATER-COOLER UNIT 16-09-00 | Shiley, Inc. | 1988-09-26 | Traditional | PDF ↗ |
| K880663 | SHILEY BCD PLUS HEAT EXCHANGER | Shiley, Inc. | 1988-05-11 | Traditional | PDF ↗ |
| K880451 | SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS | Scimed Life Systems, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K873561 | ELECTROMEDICS D1079E | Electromedics, Inc. | 1987-11-05 | Traditional | PDF ↗ |
| K870804 | CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 | American Bentley | 1987-09-01 | Traditional | PDF ↗ |
| K871774 | CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS | Gish Biomedical, Inc. | 1987-08-03 | Traditional | PDF ↗ |
| K861102 | CPS-3000 CARDIOPLEGIA RESERVOIR | Gish Biomedical, Inc. | 1986-05-28 | Traditional | PDF ↗ |
| K860920 | STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL | Shiley, Inc. | 1986-05-21 | Traditional | PDF ↗ |
| K860523 | CARDIO-COOL | Bio-Vascular, Inc. | 1986-04-29 | Traditional | PDF ↗ |
| K853791 | NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 | Norton Performance Plastics Corp. | 1985-12-09 | Traditional | PDF ↗ |
| K853516 | SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM | 3M Health Care, Sarns | 1985-11-14 | Traditional | PDF ↗ |
| K853410 | MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1985-10-11 | Traditional | PDF ↗ |
| K852780 | BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV) | Shiley, Inc. | 1985-09-30 | Traditional | PDF ↗ |
| K850794 | PATIENT MONITOR MODEL RM-300 | Honeywell, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K843983 | MYOCARDIAL INSULATOR | Norton Texas Medical Products | 1984-12-27 | Traditional | PDF ↗ |
| K840256 | CARDIOPLEGIA HEAT EXCHANGER HOLDER | American Bentley | 1984-02-17 | Traditional | PDF ↗ |
| K840045 | CARDIOPLEGIA HEAT EXCHANGER HE-100 | American Bentley | 1984-02-13 | Traditional | PDF ↗ |
| K833555 | LAL TEST RELEASE & BONCHEK CAR/JACKET | Shiley, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K833662 | CARDIOPLEGIA SYSTEM CCS-XXX SERIES | Gish Biomedical, Inc. | 1983-12-29 | Traditional | PDF ↗ |
| K832417 | HYPOTHERMIC MYCARDIAL PROTECTION DEV | 3M Health Care, Sarns | 1983-10-20 | Traditional | PDF ↗ |
| K831157 | BLOOD CARDIOPLEGIA STAINLESS STEEL COOL | American Bentley | 1983-05-09 | Traditional | PDF ↗ |
| K823451 | CLEAR CARDIOPLEJIA DELIVERY SYSTEM | 3M Health Care, Sarns | 1983-01-14 | Traditional | PDF ↗ |
| K823533 | JACKET & SET | Shiley, Inc. | 1982-12-30 | Traditional | PDF ↗ |
| K813264 | D6ZO DISPOSABLE HEAT EXCHANGER | Electromedics, Inc. | 1982-07-06 | Traditional | PDF ↗ |
| K812093 | COBE HEAT EXCHANGER RESERVOIR MODULE | Cobe Laboratories, Inc. | 1981-08-13 | Traditional | PDF ↗ |
| K811204 | BRONCHEK-SHILEY CARDIAC JACKET & BSC J | Shiley, Inc. | 1981-05-21 | Traditional | PDF ↗ |
| K802545 | CARDIOPLEGIC SETS | Texas Medical Products, Inc. | 1981-01-16 | Traditional | PDF ↗ |
| K802879 | BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL. | Shiley, Inc. | 1980-12-19 | Traditional | PDF ↗ |
| K802848 | CARDIOPLEGIA COOLING SYST. CCAS-2 | Bentley Laboratories, Inc. | 1980-12-11 | Traditional | PDF ↗ |
| K800717 | TOPICAL COOLING DEV. TCD. #27-999 | Cobe Laboratories, Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K800377 | CARDIOPLEGIA DELIVERY SYSTEM | 3M Health Care, Sarns | 1980-03-19 | Traditional | PDF ↗ |
| K791430 | MINIPRIME HYPOTHERMIC HEAT EXCHANGER | Travenol Laboratories, S.A. | 1979-08-28 | Traditional | PDF ↗ |
| K790756 | HEAT EXCHANGER COIL | Delta Medical Industries | 1979-06-11 | Traditional | PDF ↗ |
| K781764 | PAD, COOLING #27-999 | Cobe Laboratories, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K781210 | HEAT EXCHANGER, FHX-14 | Delta Medical Industries | 1978-10-10 | Traditional | PDF ↗ |
| K772117 | HEAT EXCHANGER, DISP., OMNITHERM | Scimed Life Systems, Inc. | 1978-03-02 | Traditional | PDF ↗ |
| K770016 | PACING KIT, ELECATH TRANSTHORACIC | Electro-Catheter Corp. | 1977-01-14 | Traditional | PDF ↗ |
| K770017 | PACING KIT, TRANSMYOCARDIAL | Electro-Catheter Corp. | 1977-01-14 | Traditional | PDF ↗ |
| K770018 | PACING KIT, SEMI-FLOATING | Electro-Catheter Corp. | 1977-01-14 | Traditional | PDF ↗ |
Product code DTR · Class II · Cardiovascular. Data: openFDA.