FDA 510(k), K152765, VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM

FDA 510(k), K152765, VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM

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510(K) Number: K152765
Device Name: VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
Manufacturer: PETER FLOSDORF
Device Classification Name: Filter, Intravascular, Cardiovascular
Regulation Number: DTK
Classification Product Code: KXA
Date Received: 09/24/2015
Decision Date: 02/26/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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