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FDA 510(k), K090140, GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER
FDA 510(k), K090140, GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER
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510(K) Number: K090140
Device Name: GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER
Manufacturer: MOLLY BUSENBARK
Device Classification Name: Filter, Intravascular, Cardiovascular
Regulation Number: DTK
Classification Product Code: 01/21/2009
Date Received: 04/03/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER
Manufacturer: MOLLY BUSENBARK
Device Classification Name: Filter, Intravascular, Cardiovascular
Regulation Number: DTK
Classification Product Code: 01/21/2009
Date Received: 04/03/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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