DTR · Class II · 21 CFR 870.4240

FDA Product Code DTR: Heat-exchanger, Cardiopulmonary Bypass

Leading manufacturers include Shiley, Inc., Gish Biomedical, Inc. and 3M Health Care, Sarns.

91
Total
91
Cleared
112d
Avg days
1977
Since
91 devices
49–72 of 91
Cleared Dec 05, 1988
SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM
K883071
3M Health Care, Sarns
Cardiovascular · 138d
Cleared Oct 13, 1988
INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM
K883439
Medtronic Blood Systems, Inc.
Cardiovascular · 59d
Cleared Sep 26, 1988
BASIC HEATER-COOLER UNIT, 115/100V 16-02-20
K883330
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10
K883331
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
MAST FOR BASIC HEATER-COOLER UNIT 16-09-00
K883332
Shiley, Inc.
Cardiovascular · 49d
Cleared May 11, 1988
SHILEY BCD PLUS HEAT EXCHANGER
K880663
Shiley, Inc.
Cardiovascular · 83d
Cleared Apr 28, 1988
SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS
K880451
Scimed Life Systems, Inc.
Cardiovascular · 86d
Cleared Nov 05, 1987
ELECTROMEDICS D1079E
K873561
Electromedics, Inc.
Cardiovascular · 64d
Cleared Sep 01, 1987
CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100
K870804
American Bentley
Cardiovascular · 186d
Cleared Aug 03, 1987
CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS
K871774
Gish Biomedical, Inc.
Cardiovascular · 89d
Cleared May 28, 1986
CPS-3000 CARDIOPLEGIA RESERVOIR
K861102
Gish Biomedical, Inc.
Cardiovascular · 65d
Cleared May 21, 1986
STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL
K860920
Shiley, Inc.
Cardiovascular · 71d
Cleared Apr 29, 1986
CARDIO-COOL
K860523
Bio-Vascular, Inc.
Cardiovascular · 76d
Cleared Dec 09, 1985
NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000
K853791
Norton Performance Plastics Corp.
Cardiovascular · 89d
Cleared Nov 14, 1985
SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM
K853516
3M Health Care, Sarns
Cardiovascular · 84d
Cleared Oct 11, 1985
MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD
K853410
Intermedics, Inc.
Cardiovascular · 59d
Cleared Sep 30, 1985
BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)
K852780
Shiley, Inc.
Cardiovascular · 91d
Cleared Apr 18, 1985
PATIENT MONITOR MODEL RM-300
K850794
Honeywell, Inc.
Cardiovascular · 51d
Cleared Dec 27, 1984
MYOCARDIAL INSULATOR
K843983
Norton Texas Medical Products
Cardiovascular · 77d
Cleared Feb 17, 1984
CARDIOPLEGIA HEAT EXCHANGER HOLDER
K840256
American Bentley
Cardiovascular · 25d
Cleared Feb 13, 1984
CARDIOPLEGIA HEAT EXCHANGER HE-100
K840045
American Bentley
Cardiovascular · 38d
Cleared Feb 04, 1984
LAL TEST RELEASE & BONCHEK CAR/JACKET
K833555
Shiley, Inc.
Cardiovascular · 110d
Cleared Dec 29, 1983
CARDIOPLEGIA SYSTEM CCS-XXX SERIES
K833662
Gish Biomedical, Inc.
Cardiovascular · 72d
Cleared Oct 20, 1983
HYPOTHERMIC MYCARDIAL PROTECTION DEV
K832417
3M Health Care, Sarns
Cardiovascular · 91d