FDA 510(k), K061815, COOK CELECT VENA CAVA FILTER

FDA 510(k), K061815, COOK CELECT VENA CAVA FILTER

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510(K) Number: K061815
Device Name: COOK CELECT VENA CAVA FILTER
Manufacturer: THALIA BRINE
Device Classification Name: Filter, Intravascular, Cardiovascular
Regulation Number: DTK
Classification Product Code: KXA
Date Received: 06/27/2006
Decision Date: 04/20/2007
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

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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