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 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 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
Cleared May 09, 1983
BLOOD CARDIOPLEGIA STAINLESS STEEL COOL
K831157
American Bentley
Cardiovascular · 31d
Cleared Jan 14, 1983
CLEAR CARDIOPLEJIA DELIVERY SYSTEM
K823451
3M Health Care, Sarns
Cardiovascular · 58d
Cleared Dec 30, 1982
JACKET & SET
K823533
Shiley, Inc.
Cardiovascular · 31d
Cleared Jul 06, 1982
D6ZO DISPOSABLE HEAT EXCHANGER
K813264
Electromedics, Inc.
Cardiovascular · 228d
Cleared Aug 13, 1981
COBE HEAT EXCHANGER RESERVOIR MODULE
K812093
Cobe Laboratories, Inc.
Cardiovascular · 20d
Cleared May 21, 1981
BRONCHEK-SHILEY CARDIAC JACKET & BSC J
K811204
Shiley, Inc.
Cardiovascular · 20d