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Panels › Anesthesiology › Product code CAC · Class 2

Apparatus, Autotransfusion

Regulation 868.5830

0510(k)s in 12 months (195 all time)

0recalls in 12 months (114 all time)

99recalls that name a 510(k)

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Top companies in CAC

Company	510(k)s	Recalls
Haemonetics Corp.	18	39
Atrium Medical Corp.	10	19
Stryker Instruments Div. of Stryker Corporation	0	29
Cobe Cardiovascular, Inc.	7	10
Boehringer Laboratories	12	1
Deknatel, Inc.	11	0
Shiley, Inc.	11	0
Electromedics, Inc.	7	0
Fresenius Kabi AG	4	3
Solco Basle, Inc.	7	0

Date	Firm and product	Code	Linked 510(k)
Aug 3, 2005	Cobe Cardiovascular, Inc ASY, Brat 2 Procedure Set Terminated	CAC	K933625
Aug 3, 2005	Cobe Cardiovascular, Inc ASY Brat 2 Procedure Set Terminated	CAC	K933625
Aug 3, 2005	Cobe Cardiovascular, Inc ASY, Brat Pack Procedure Set Terminated	CAC	K933625
Aug 3, 2005	Cobe Cardiovascular, Inc ASY Brat 2 Procedure Set Terminated	CAC	K933625
Aug 3, 2005	Cobe Cardiovascular, Inc ASY, Brat 2 Pack Procedure Set Terminated	CAC	K933625
Aug 3, 2005	Cobe Cardiovascular, Inc ASY Brat 2 Procedure Set, for blood recovery & autotransfusion. Terminated	CAC	K933625
Dec 17, 2003	Boehringer Laboratories Inc Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units Terminated	CAC	K932093
Jun 5, 2003	Fresenius Hemocare, Inc. ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. The component that is the subject of the recall is the AT1 Autotransfusi Terminated	CAC	K012178 K960006 +1
Jan 30, 2003	Haemonetics Corporation Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number: 265F Terminated	CAC	K932890
Jan 30, 2003	Haemonetics Corporation Haemonetics Cell Saver 5 Low Volume (125mL) Fast Pack List Number: 265 Terminated	CAC	K932890
Jan 30, 2003	Haemonetics Corporation Haemonetics High Speed Cell Saver Bowl Set List Number: 263 Terminated	CAC	K932890
Jan 30, 2003	Haemonetics Corporation Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261 Terminated	CAC	K932890
Jan 30, 2003	Haemonetics Corporation Haemonetics Cell Saver 5 Fast Pack with Filtered Reservoir List Number: 260F Terminated	CAC	K932890
Jan 30, 2003	Haemonetics Corporation Haemonetics Cell Saver 5 Fast Pack List Number: 260 Terminated	CAC	K932890

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