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FDA 510(k), K181126, Reprocessed Visions PV .035 Digital IVUS Catheter
FDA 510(k), K181126, Reprocessed Visions PV .035 Digital IVUS Catheter
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$149.00 USD
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510(K) Number: K181126
Device Name: Reprocessed Visions PV .035 Digital IVUS Catheter
Manufacturer: Amanda Babcock
Device Classification Name: Reprocessed Intravascular Ultrasound Catheter
Regulation Number: OWQ
Classification Product Code: 04/30/2018
Date Received: 01/18/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Reprocessed Visions PV .035 Digital IVUS Catheter
Manufacturer: Amanda Babcock
Device Classification Name: Reprocessed Intravascular Ultrasound Catheter
Regulation Number: OWQ
Classification Product Code: 04/30/2018
Date Received: 01/18/2019
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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