CAC · Class II · 21 CFR 868.5830

FDA Product Code CAC: Apparatus, Autotransfusion

Recovering the patient's own shed blood reduces transfusion requirements during surgery. FDA product code CAC covers autotransfusion apparatus used in operative and post-operative blood recovery.

These systems collect, filter, wash, and reinfuse the patient's own shed blood during cardiac, vascular, and orthopedic surgery. Autotransfusion reduces allogeneic blood exposure and its associated risks, including transfusion reactions and infection transmission.

CAC devices are Class II medical devices, regulated under 21 CFR 868.5830 and reviewed by the FDA Hematology panel.

Leading manufacturers include Haemonetics Corp., Boehringer Laboratories and Deknatel, Inc..

195
Total
195
Cleared
153d
Avg days
1977
Since
195 devices
49–72 of 195
Cleared Aug 20, 1998
MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
K982755
Medtronic Blood Management
Anesthesiology · 52d
Cleared Apr 27, 1998
AUTOTRANSFUSION APPARTUS (AUTOLOG)
K972894
Medtronic Blood Management
Anesthesiology · 265d
Cleared Mar 31, 1998
COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
K974897
Cobe Cardiovascular, Inc.
Anesthesiology · 90d
Cleared Feb 20, 1998
CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE
K963758
Sorin Biomedical, Inc.
Anesthesiology · 520d
Cleared Feb 20, 1998
DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
K963759
Sorin Biomedical, Inc.
Anesthesiology · 520d
Cleared Dec 16, 1997
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K970714
Stryker Instruments
Anesthesiology · 292d
Cleared Nov 05, 1997
ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO
K970857
Davis & Geck, Inc.
Anesthesiology · 240d
Cleared Nov 03, 1997
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
K973378
Fresenius USA, Inc.
Anesthesiology · 56d
Cleared Nov 03, 1997
STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
K973627
Cobe Cardiovascular, Inc.
Anesthesiology · 40d
Cleared Jun 13, 1997
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET
K971274
Fresenius AG
Anesthesiology · 67d
Cleared Apr 22, 1997
PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K963850
Deknatel, Inc.
Anesthesiology · 209d
Cleared Feb 20, 1997
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
K962475
Transfusion Technologies Corp.
Anesthesiology · 240d
Cleared Jan 28, 1997
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP)
K962689
Cobe Cardiovascular, Inc.
Anesthesiology · 201d
Cleared Dec 31, 1996
DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
K964070
Deknatel, Inc.
Anesthesiology · 82d
Cleared Dec 10, 1996
HAEMOCELL SYSTEM 350 OR S350
K960734
Haemocell Plc
Anesthesiology · 292d
Cleared Nov 08, 1996
PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)
K963098
Deknatel, Inc.
Anesthesiology · 91d
Cleared Jul 31, 1996
C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM
K960006
Fresenius AG
Anesthesiology · 211d
Cleared Jun 20, 1996
AUTOVAC BP SYSTE, 2000 SERIES
K955010
Boehringer Laboratories
Anesthesiology · 232d
Cleared Apr 26, 1996
LEVEL 1 BLOOD STREAM RECOVERY SYSTEM
K942844
Level 1 Technologies, Inc.
Anesthesiology · 680d
Cleared Mar 04, 1996
BETATRANS I AND II
K951592
Duxbury Scientific, Inc.
Anesthesiology · 333d
Cleared Feb 23, 1996
CARACELL
K953118
Medtronic Vascular
Anesthesiology · 235d
Cleared Nov 17, 1995
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K952224
Stryker Instruments
Anesthesiology · 189d
Cleared Oct 19, 1995
BOEHRINGER AUTOVAC(R) 7900 SERIES
K945775
Boehringer Laboratories
Anesthesiology · 328d
Cleared Jul 20, 1995
AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS
K944232
Haemonetics Corp.
Anesthesiology · 322d