FDA 510(k), K143459, Silk Road Acccess Catheter

FDA 510(k), K143459, Silk Road Acccess Catheter

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510(K) Number: K143459
Device Name: Silk Road Acccess Catheter
Manufacturer: SILK ROAD MEDICAL, INC
Device Classification Name: Catheter, Percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 12/04/2014
Decision Date: 04/01/2015
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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