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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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$149.00 USD
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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: 01/27/2020
Date Received: 06/22/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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: 01/27/2020
Date Received: 06/22/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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