ClearanceBrief
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

DateFirm and productCodeLinked 510(k)
Jan 14, 2014Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or medi
Terminated
CACK043140
K043582
Jan 14, 2014Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air and/or fluid from the
Terminated
CACK043140
K043582
Jan 14, 2014Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or medi
Terminated
CACK043140
K043582
Jan 14, 2014Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest
Terminated
CACK043140
K043582
Jan 14, 2014Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or me
Terminated
CACK043140
K043582
Aug 5, 2011Haemonetics Corporation
Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the US: 02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JA The Haemonetics C
Terminated
CACK053000
Jun 7, 2011Haemonetics Corporation
Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only: 1050-110-ENG Outside US: 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, 105
Terminated
CACK992723
Feb 22, 2011Haemonetics Corporation
Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US
Terminated
CACK053000
Nov 10, 2010Fresenius Kabi, LLC
The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a phy
Terminated
CACK960006
Nov 10, 2010Fresenius Kabi, LLC
The box label states: "ATF 40 Fast Start Kit 9108491...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a phys
Terminated
CACK960006
Nov 10, 2010Fresenius Kabi, LLC
The box label states: "AT1 Autotransfusion Set 9005101 STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a phys
Terminated
CACK960006
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBC ConstaVac Blood Conservation Kit 3/16in. (4.8mm) PVC, sterile, Stryker Instruments, Kalamazoo, MI REF 225-426-W. Blood recovery system used post-operatively to collect, filter and allow f
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII Collection only pkg/6 with 1/8 in Trocar, sterile, Stryker Instruments, Kalamazoo, MI, REF 0225-028-S21. Blood recovery system used post-operatively to collect, filter and allow for rei
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII with 3/16 in. Silicone Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 0225-028-S16. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII ConstaVac Blood Conservation Kit 3/16in. (4.8 mm) PVC, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-426. Blood recovery system used post-operatively to collect, filter and allo
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII ConstaVac Blood Conservation Kit 1/4in. (6.4mm) PVC, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-416. Blood recovery system used post-operatively to collect, filter and allow
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII ConstaVac Blood Conservaion Kit 1/8in. (3.2mm) PVC, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-414-W. Blood recovery system used post-operatively to collect, filter and allow
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII ConstaVac Blood Conservation Kit 1/8in. (3.2mm) PVC w/o Fat Retention Valve, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-414S2. Blood recovery system used post-operatively to
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII ConstaVAc Blood Conservatin Kit 1/8in. (3.2mm) PVC, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-414. Blood recovery system used post-operatively to collect, filter and allow f
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII ConstaVac Blood Collection Only System with 1/8in. (3.2mm) PVC Drains and Double 1/8in. (3.2mm) Trocar, sterile, Stryker Instruments, Kalamazoo, MI REF 225-29. Blood recovery system us
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII ConstaVac Blood Conservation System w/Quick Disconnect and 3/16in. (4.8mm) PVC Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-926. Blood recovery system used post-operat
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII ConstaVac Blood Conservation System with Quick Disconnect and 1/4in. (6.4mm) PVC Drain, sterile, Stryker Instruments, Kalamazoo, MI REF 225-28-916. Blood recovery system used post-op
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII ConstaVac Blood Conservagtion System w/ Quick Disconnect and 1/8in. (3.2mm) PVC Drain, sterile, Stryker Instruments, Kalamazoo, MI REF 225-28-914. Blood recovery system used post-oper
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII Double Trocar/Double Pouch Kit with 3/16in. (4.8mm) Drain, sterile, Stryker Instruments, Kalamazoo, MI REF 225-28-626S1. Blood recovery system used post-operatively to collect, filter
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII Double Trocar Kit with 3/16in. (4.8mm) Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-626. Blood recovery system used post-operatively to collect, filter and allow for
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII Double Trocar Kit with 1/4in. (6.4mm) Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-616. Blood recovery system used post-operatively to collect, filter and allow for
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII Double Trocar Kit with 1/8 in. (3.2mm) Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-614. Blood recovery system used post-operatively to collect, filter and allow for r
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII Blood Conservation Kit w 3/16in. (4.8mm) round PVC Drain and Curved Trocar, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-526. Blood recovery system used post-operatively to
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII Blood Conservation Kit w/ 1/4 in. (6.4mm) Round PVC Drain and Curved Trocar, sterile, Stryker Instruments, Kalamzoo, MI, REF 225-28-516. Blood recovery system used post-operatively t
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII Blood Conservation Kit w/ 1/8 in. (3.2mm) Round PVC Drain and Curved Trocar, sterile, Stryker Instruments, Kalamzoo, MI; REF 225-28-514. Blood recovery system used post-operatively to c
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII with Quick Disconnect and 3/16 in. Double Trocar, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-S5. Blood recovery system used post-operatively to collect, filter and allow f
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII with Quick Disconnect, 3/16 in. Double Trocar and Reinfusion Labels, sterile Stryker Instruments, Kalamazoo, MI, REF 225-28-85S4. Blood recovery system used post-operatively to colle
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII 1/8in. Double Trocar with quick disconnect , sterile, Stryker Instuments, Kalamazoo, MI, REF225-28-85S1. Blood recovery system used post-operatively to collect, filter and allow f
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBC Blood Conservation Kit with Quick Disconnect Blood Bag, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-85. Blood recovery system used post-operatively to collect, filter and a
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII collection only pkg/6, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-S20. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autol
Terminated
CACK952224
Jan 29, 2010Stryker Instruments Div. of Stryker Corporation
Stryker CBCII ConstaVac Blood conservation system, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28E. Blood recovery system used post-operatively to collect, filter and allow for reinfusio
Terminated
CACK952224
Sep 19, 2008Zimmer Inc.
Zimmer H.A.S. Autotransfusion System, H.A.S. Kit without Drain, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-060-05.
Terminated
CACNone listed
Sep 19, 2008Zimmer Inc.
Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-050-05.
Terminated
CACNone listed
Sep 19, 2008Zimmer Inc.
Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-
Terminated
CACNone listed
Sep 19, 2008Zimmer Inc.
Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 3/16" Soft Drain , 4,8mm, 15Fr, PVC, 107cm, firm, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio;
Terminated
CACNone listed
Sep 19, 2008Zimmer Inc.
Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 0
Terminated
CACNone listed
Dec 8, 2007Haemonetics Corporation
Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)
Terminated
CACK053000
Feb 15, 2007Atrium Medical Corporation
Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
Terminated
CACK043140
Sep 9, 2006Cobe Cardiovascular, Inc
Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc.
Terminated
CACK020647
Sep 9, 2006Cobe Cardiovascular, Inc
Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. Cobe Cardiovascular Inc.
Terminated
CACK982650
Sep 9, 2006Cobe Cardiovascular, Inc
dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E, WS125E, WS175E, WS225E, Cobe Cardiovascular, Inc.
Terminated
CACK020647
Sep 9, 2006Cobe Cardiovascular, Inc
dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, Cobe Cardiovascular, Inc.
Terminated
CACK982650
Apr 29, 2006Haemonetics Corporation
Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP
Terminated
CACK014083
Apr 29, 2006Haemonetics Corporation
Haemonetics Cell Saver 5 Autogolous Blood Recovery System Model Numbr: LN02005-110-E
Terminated
CACK014083
Nov 23, 2005Haemonetics Corporation
cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables: cardioPAT Replacement RBC Bags, LN 00270 cardioPAT Replacement Waste Bags, LN 00271 cardioPAT Repl
Terminated
CACK043127

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