DWA · Class II · 21 CFR 870.4380

FDA Product Code DWA: Control, Pump Speed, Cardiopulmonary Bypass

Leading manufacturers include Medtronic Bio-Medicus, Inc., Levitronix, LLC and Bio Medicus, Inc..

37
Total
37
Cleared
115d
Avg days
1978
Since
37 devices
25–37 of 37
Cleared May 14, 1998
BARD ISOFLOW BLOOD PUMP
K971421
C.R. Bard, Inc.
Cardiovascular · 393d
Cleared Nov 17, 1995
3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
K950739
3M Health Care, Sarns
Cardiovascular · 273d
Cleared Dec 23, 1994
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER
K936091
Medtronic Bio-Medicus, Inc.
Cardiovascular · 366d
Cleared Jul 20, 1994
BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550
K941921
Medtronic Bio-Medicus, Inc.
Cardiovascular · 91d
Cleared Jun 02, 1993
MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150
K926357
Medtronic Bio-Medicus, Inc.
Cardiovascular · 163d
Cleared May 07, 1993
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E
K924206
Medtronic Bio-Medicus, Inc.
Cardiovascular · 260d
Cleared May 06, 1993
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550
K924205
Medtronic Bio-Medicus, Inc.
Cardiovascular · 259d
Cleared May 20, 1992
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D
K914754
Medtronic Bio-Medicus, Inc.
Cardiovascular · 211d
Cleared Jun 28, 1990
BIO-MEDICUS BIO CONSOLE MODELS 540 A B C
K901584
Bio Medicus, Inc.
Cardiovascular · 85d
Cleared Jan 08, 1986
BIO MEDICUS BIO CONSOLE 540
K854133
Bio Medicus, Inc.
Cardiovascular · 90d
Cleared Oct 11, 1985
BIO PACK MODEL 200
K853126
Bio Medicus, Inc.
Cardiovascular · 78d
Cleared Aug 10, 1984
GAMBRO PULSATILE MONITOR PLM 10-200
K842503
Gambro, Inc.
Cardiovascular · 45d
Cleared Aug 31, 1978
MODEL 1812 CONTROL CONSOLE, ACCESSORIEX
K780952
Medtronic Vascular
Cardiovascular · 83d