FDA 510(k), K200195, NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

FDA 510(k), K200195, NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

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510(K) Number: K200195
Device Name: NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
Manufacturer: Matthew Farley
Device Classification Name: Catheter, Ultrasound, Intravascular
Regulation Number: OBJ
Classification Product Code: KXA
Date Received: 01/27/2020
Decision Date: 06/22/2020
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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