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FDA 510(k), K072240, GUNTHER TULIP VENA CAVA FILTER
FDA 510(k), K072240, GUNTHER TULIP VENA CAVA FILTER
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510(K) Number: K072240
Device Name: GUNTHER TULIP VENA CAVA FILTER
Manufacturer: MOLLY BUSENBARK
Device Classification Name: Filter, Intravascular, Cardiovascular
Regulation Number: DTK
Classification Product Code: KXA
Date Received: 08/13/2007
Decision Date: 11/08/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: GUNTHER TULIP VENA CAVA FILTER
Manufacturer: MOLLY BUSENBARK
Device Classification Name: Filter, Intravascular, Cardiovascular
Regulation Number: DTK
Classification Product Code: KXA
Date Received: 08/13/2007
Decision Date: 11/08/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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