KRI · Class I · 21 CFR 870.4200

FDA Product Code KRI: Accessory Equipment, Cardiopulmonary Bypass

Leading manufacturers include American Bentley, Shiley, Inc. and Texas Medical Products, Inc..

42
Total
42
Cleared
66d
Avg days
1977
Since

FDA 510(k) Cleared Accessory Equipment, Cardiopulmonary Bypass Devices (Product Code KRI)

42 devices
1–24 of 42
Cleared Feb 02, 1988
HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
K874605
Mallinckrodt Critical Care
Cardiovascular · 85d
Cleared Feb 19, 1987
STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP
K864890
Shiley, Inc.
Cardiovascular · 66d
Cleared Jul 17, 1986
STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1
K862510
Shiley, Inc.
Cardiovascular · 16d
Cleared Jul 15, 1986
ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE
K862549
American Bentley
Cardiovascular · 12d
Cleared Mar 03, 1986
ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL
K860672
American Bentley
Cardiovascular · 7d
Cleared Jan 08, 1986
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
K854113
American Bentley
Cardiovascular · 92d
Cleared Sep 16, 1985
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200
K852455
Gambro, Inc.
Cardiovascular · 98d
Cleared Jun 19, 1985
COBE GAS FILTER
K851289
Cobe Laboratories, Inc.
Cardiovascular · 79d
Cleared Jun 11, 1984
TUBE TENDER
K841296
The Anspach Effort, Inc.
Cardiovascular · 73d
Cleared Jun 11, 1984
HOLDER FOR BOS-10, 10S 5S
K841812
American Bentley
Cardiovascular · 41d
Cleared Apr 17, 1984
HOLDER FOR MODELS AF-10,1025,1040,5
K841032
American Bentley
Cardiovascular · 36d
Cleared Sep 29, 1983
SHILEY GAS FILTER
K832704
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 12, 1983
GASLINE FILTER #GF-10
K832411
American Bentley
Cardiovascular · 53d
Cleared Mar 11, 1983
HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-
K830167
American Bentley
Cardiovascular · 52d
Cleared Jul 30, 1982
D645-BACTERIOLOGICAL GAS LINE FILTER
K822097
Electromedics, Inc.
Cardiovascular · 14d
Cleared Mar 02, 1982
TMO INTEGRATED CIRCUIT SYSTEM
K820406
Travenol Laboratories, S.A.
Cardiovascular · 18d
Cleared Jun 09, 1981
CARDIOPLEGIA COOLING & ADMIN. SETS
K811368
Bentley Laboratories, Inc.
Cardiovascular · 26d
Cleared May 29, 1981
CARDIOPULMONARY BYPASS ACCESSORY EQUIP.
K811348
Bentley Laboratories, Inc.
Cardiovascular · 16d
Cleared Jan 30, 1981
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
K810079
3M Health Care, Sarns
Cardiovascular · 17d
Cleared Jan 16, 1981
DISPOSABLE GAS LINE FILTER
K802539
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
DISPOSABLE PARALLEL Y CONNECTORS
K802541
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
DISPOSABLE CONNECTORS
K802542
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Dec 16, 1980
WILLIAM HARVEY OXYGENATING GAS FILTER
K802906
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Oct 02, 1979
SHILEY QUICK DISCONNECT ASSEMBLY
K791829
Shiley, Inc.
Cardiovascular · 15d

About Product Code KRI - Regulatory Context