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 Dec 20, 1999
INTERFACE MODULE IDDD
K992635
Stoeckert Instrumente
Cardiovascular · 136d
Cleared Nov 23, 1999
STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS
K990512
Stoeckert Instrumente
Cardiovascular · 278d
Cleared Jan 30, 1989
CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25
K884893
American Omni Medical, Inc.
Cardiovascular · 69d
Cleared Jan 24, 1989
CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700
K884640
American Omni Medical, Inc.
Cardiovascular · 78d
Cleared Feb 02, 1988
HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
K874605
Mallinckrodt Critical Care
Cardiovascular · 85d
Cleared Jan 19, 1988
CPE 2000 CARDIO PULMONARY ERGOMETER
K874925
Medical Graphics Corp.
Cardiovascular · 48d
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 Apr 02, 1986
STABLELINE
K860298
Cardio Metrics, Inc.
Cardiovascular · 64d
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

About Product Code KRI - Regulatory Context