Atlas FDA

STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)

FDA 510(k) clearance K952224 · decided 1995-11-17

Clearance details

K-number
K952224
Device name
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
Applicant
Stryker Instruments
Decision
Substantially Equivalent
Date received
1995-05-12
Decision date
1995-11-17
Days to decision
189 days
Clearance type
Traditional
Product code
CAC
Device class
2
Regulation number
868.5830
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stryker CBCII ConstaVac Blood conservation system, sterile, Stryker Instruments, Kalamazoo recall (Z-0719-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII collection only pkg/6, sterile, Stryker Instruments, Kalamazoo, MI, REF 225- recall (Z-0720-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBC Blood Conservation Kit with Quick Disconnect Blood Bag, sterile, Stryker Instr recall (Z-0721-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII 1/8in. Double Trocar with quick disconnect , sterile, Stryker Instuments, Ka recall (Z-0722-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII with Quick Disconnect, 3/16 in. Double Trocar and Reinfusion Labels, sterile recall (Z-0723-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII with Quick Disconnect and 3/16 in. Double Trocar, sterile, Stryker Instrumen recall (Z-0724-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII Blood Conservation Kit w/ 1/8 in. (3.2mm) Round PVC Drain and Curved Trocar, recall (Z-0725-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII Blood Conservation Kit w/ 1/4 in. (6.4mm) Round PVC Drain and Curved Trocar, recall (Z-0726-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII Blood Conservation Kit w 3/16in. (4.8mm) round PVC Drain and Curved Trocar, recall (Z-0727-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII Double Trocar Kit with 1/8 in. (3.2mm) Drain, sterile, Stryker Instruments, recall (Z-0728-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII Double Trocar Kit with 1/4in. (6.4mm) Drain, sterile, Stryker Instruments, K recall (Z-0729-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII Double Trocar Kit with 3/16in. (4.8mm) Drain, sterile, Stryker Instruments, recall (Z-0730-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII Double Trocar/Double Pouch Kit with 3/16in. (4.8mm) Drain, sterile, Stryker recall (Z-0731-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII ConstaVac Blood Conservagtion System w/ Quick Disconnect and 1/8in. (3.2mm) recall (Z-0732-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII ConstaVac Blood Conservation System with Quick Disconnect and 1/4in. (6.4mm) recall (Z-0733-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII ConstaVac Blood Conservation System w/Quick Disconnect and 3/16in. (4.8mm) P recall (Z-0734-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII ConstaVac Blood Collection Only System with 1/8in. (3.2mm) PVC Drains and Do recall (Z-0735-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII ConstaVAc Blood Conservatin Kit 1/8in. (3.2mm) PVC, sterile, Stryker Instrum recall (Z-0736-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII ConstaVac Blood Conservation Kit 1/8in. (3.2mm) PVC w/o Fat Retention Valve, recall (Z-0737-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII ConstaVac Blood Conservaion Kit 1/8in. (3.2mm) PVC, sterile, Stryker Instrum recall (Z-0738-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII ConstaVac Blood Conservation Kit 1/4in. (6.4mm) PVC, sterile, Stryker Instru recall (Z-0739-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII ConstaVac Blood Conservation Kit 3/16in. (4.8 mm) PVC, sterile, Stryker Inst recall (Z-0740-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII with 3/16 in. Silicone Drain, sterile, Stryker Instruments, Kalamazoo, MI, R recall (Z-0741-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBCII Collection only pkg/6 with 1/8 in Trocar, sterile, Stryker Instruments, Kala recall (Z-0742-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29
Stryker CBC ConstaVac Blood Conservation Kit 3/16in. (4.8mm) PVC, sterile, Stryker Instrum recall (Z-0743-2010)Stryker Instruments Div. of Stryker Corporation2010-01-29