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 Shiley, 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 Oct 24, 2008
PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
K082923
Life-Tech, Inc.
Anesthesiology · 23d
Cleared Sep 28, 2006
CYTORI CELUTION CELL CONCENTRATION DEVICE
K060482
Cytori Therapeutics, Inc.
Anesthesiology · 217d
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 Jul 25, 2003
S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K031554
Genzyme Biosurgery
Anesthesiology · 67d
Cleared Mar 07, 2003
PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
K022167
Pall Corp.
Anesthesiology · 247d
Cleared Feb 14, 2003
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14
K024097
Summit Medical , Ltd.
Anesthesiology · 64d
Cleared Oct 09, 2002
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
K022489
Summit Medical , Ltd.
Anesthesiology · 72d
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 Jul 23, 2001
FRESENIUS C.A.T.S
K012178
Fresenius Hemotechnology, Inc.
Anesthesiology · 11d
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