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FDA 510(k), K901454, VENA CAVA FILTER
FDA 510(k), K901454, VENA CAVA FILTER
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510(K) Number: K901454
Device Name: VENA CAVA FILTER
Manufacturer: PAUL O'CONNELL
Device Classification Name: Filter, Intravascular, Cardiovascular
Regulation Number: DTK
Classification Product Code: KXA
Date Received: 03/27/1990
Decision Date: 05/29/1991
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: VENA CAVA FILTER
Manufacturer: PAUL O'CONNELL
Device Classification Name: Filter, Intravascular, Cardiovascular
Regulation Number: DTK
Classification Product Code: KXA
Date Received: 03/27/1990
Decision Date: 05/29/1991
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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