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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)
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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
Sep 26, 1988K883332MAST FOR BASIC HEATER-COOLER UNIT 16-09-00
Shiley, Inc.
DTR
Sep 26, 1988K883331BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10
Shiley, Inc.
DTR
Sep 26, 1988K883330BASIC HEATER-COOLER UNIT, 115/100V 16-02-20
Shiley, Inc.
DTR
May 11, 1988K880663SHILEY BCD PLUS HEAT EXCHANGER
Shiley, Inc.
DTR
Apr 28, 1988K880451SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS
Scimed Life Systems, Inc.
DTR
Nov 5, 1987K873561ELECTROMEDICS D1079E
Electromedics, Inc.
DTR
Sep 1, 1987K870804CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100
American Bentley
DTR
Aug 3, 1987K871774CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS
Gish Biomedical, Inc.
DTR
May 28, 1986K861102CPS-3000 CARDIOPLEGIA RESERVOIR
Gish Biomedical, Inc.
DTR
May 21, 1986K860920STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL
Shiley, Inc.
DTR
Apr 29, 1986K860523CARDIO-COOL
Bio-Vascular, Inc.
DTR
Dec 9, 1985K853791NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000
Norton Performance Plastics Corp.
DTR
Nov 14, 1985K853516SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM
3M Health Care, Sarns
DTR
Oct 11, 1985K853410MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD
Intermedics, Inc.
DTR
Sep 30, 1985K852780BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)
Shiley, Inc.
DTR
Apr 18, 1985K850794PATIENT MONITOR MODEL RM-300
Honeywell, Inc.
DTR
Dec 27, 1984K843983MYOCARDIAL INSULATOR
Norton Texas Medical Products
DTR
Feb 17, 1984K840256CARDIOPLEGIA HEAT EXCHANGER HOLDER
American Bentley
DTR
Feb 13, 1984K840045CARDIOPLEGIA HEAT EXCHANGER HE-100
American Bentley
DTR
Feb 4, 1984K833555LAL TEST RELEASE & BONCHEK CAR/JACKET
Shiley, Inc.
DTR
Dec 29, 1983K833662CARDIOPLEGIA SYSTEM CCS-XXX SERIES
Gish Biomedical, Inc.
DTR
Oct 20, 1983K832417HYPOTHERMIC MYCARDIAL PROTECTION DEV
3M Health Care, Sarns
DTR
May 9, 1983K831157BLOOD CARDIOPLEGIA STAINLESS STEEL COOL
American Bentley
DTR
Jan 14, 1983K823451CLEAR CARDIOPLEJIA DELIVERY SYSTEM
3M Health Care, Sarns
DTR
Dec 30, 1982K823533JACKET & SET
Shiley, Inc.
DTR
Jul 6, 1982K813264D6ZO DISPOSABLE HEAT EXCHANGER
Electromedics, Inc.
DTR
Aug 13, 1981K812093COBE HEAT EXCHANGER RESERVOIR MODULE
Cobe Laboratories, Inc.
DTR
May 21, 1981K811204BRONCHEK-SHILEY CARDIAC JACKET & BSC J
Shiley, Inc.
DTR
Jan 16, 1981K802545CARDIOPLEGIC SETS
Texas Medical Products, Inc.
DTR
Dec 19, 1980K802879BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.
Shiley, Inc.
DTR
Dec 11, 1980K802848CARDIOPLEGIA COOLING SYST. CCAS-2
Bentley Laboratories, Inc.
DTR
Apr 16, 1980K800717TOPICAL COOLING DEV. TCD. #27-999
Cobe Laboratories, Inc.
DTR
Mar 19, 1980K800377CARDIOPLEGIA DELIVERY SYSTEM
3M Health Care, Sarns
DTR
Aug 28, 1979K791430MINIPRIME HYPOTHERMIC HEAT EXCHANGER
Travenol Laboratories, S.A.
DTR
Jun 11, 1979K790756HEAT EXCHANGER COIL
Delta Medical Industries
DTR
Dec 4, 1978K781764PAD, COOLING #27-999
Cobe Laboratories, Inc.
DTR
Oct 10, 1978K781210HEAT EXCHANGER, FHX-14
Delta Medical Industries
DTR
Mar 2, 1978K772117HEAT EXCHANGER, DISP., OMNITHERM
Scimed Life Systems, Inc.
DTR
Jan 14, 1977K770018PACING KIT, SEMI-FLOATING
Electro-Catheter Corp.
DTR
Jan 14, 1977K770017PACING KIT, TRANSMYOCARDIAL
Electro-Catheter Corp.
DTR
Jan 14, 1977K770016PACING KIT, ELECATH TRANSTHORACIC
Electro-Catheter Corp.
DTR

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