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
25–48 of 195
Cleared Sep 06, 2011
XTRA
K112245
Sorin Group Italia S.R.L.
Anesthesiology · 33d
Cleared Apr 07, 2011
XVAC
K110782
Sorin Group Italia S.R.L.
Anesthesiology · 17d
Cleared Dec 03, 2010
HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
K101907
Haemonetics Corp.
Anesthesiology · 148d
Cleared Nov 23, 2010
PREASSEMBLED SURGICAL WASH SET
K103202
Sorin Group Italia S.R.L.
Anesthesiology · 22d
Cleared Oct 05, 2010
XTRA AUTOTRANSFUSION SYSTEM
K101586
Sorin Group Italia S.R.L.
Anesthesiology · 120d
Cleared Mar 22, 2010
AUTOLOG AUTOTRANSFUSION SYSTEM
K093535
Medtronic, Inc.
Anesthesiology · 126d
Cleared Nov 21, 2005
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
K053000
Haemonetics Corp.
Anesthesiology · 27d
Cleared Jan 04, 2005
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
K043127
Haemonetics Corp.
Anesthesiology · 53d
Cleared Dec 08, 2004
EXPRESS AND OASIS CHEST DRAIN
K043140
Atrium Medical Corp.
Anesthesiology · 23d
Cleared Oct 14, 2004
HEMOVAC BLOOD REINFUSION SYSTEM
K041525
Zimmer, Inc.
Anesthesiology · 128d
Cleared Sep 05, 2002
DIDECO ELECTA
K020647
Dideco S.P.A.
Anesthesiology · 189d
Cleared Aug 15, 2002
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
K022348
Interpore Cross Intl.
Anesthesiology · 27d
Cleared Mar 26, 2002
ACCESS SEQUESTRATION SYSTEM
K012406
Interpore Cross Intl.
Anesthesiology · 239d
Cleared Feb 06, 2002
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
K014187
Boehringer Laboratories
Anesthesiology · 47d
Cleared Jan 08, 2002
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
K014083
Haemonetics Corp.
Anesthesiology · 28d
Cleared Nov 18, 1999
HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
K993581
Haemonetics Corp.
Anesthesiology · 27d
Cleared Oct 18, 1999
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
K992723
Transfusion Technologies Corp.
Anesthesiology · 66d
Cleared Sep 09, 1999
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
K991986
Cobe Cardiovascular, Inc.
Hematology · 87d
Cleared Apr 02, 1999
SMARTCELL PROCESSING SYSTEM
K983022
Harvest Technologies, LLC
Anesthesiology · 214d
Cleared Mar 30, 1999
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
K982660
Transfusion Technologies Corp.
Anesthesiology · 243d
Cleared Feb 01, 1999
C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE
K984233
Fresenius Hemotechnology, Inc.
Anesthesiology · 68d
Cleared Dec 18, 1998
RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
K982712
Genzyme Surgical Product (Genzyme Biosurgery)
Anesthesiology · 136d
Cleared Dec 16, 1998
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
K982650
Dideco S.P.A.
Anesthesiology · 139d
Cleared Nov 30, 1998
BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
K982241
Duxbury Scientific, Inc.
Anesthesiology · 158d