FDA 510(k), K191680, AZUR Vascular Plug
FDA 510(k), K191680, AZUR Vascular Plug
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510(K) Number: K191680
Device Name: AZUR Vascular Plug
Manufacturer: MicroVention Inc.
Device Classification Name: device, vascular, for promoting embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 06/24/2019
Decision Date: 03/20/2020
Regulation Medical Specialty: Cardiovascular
Device Name: AZUR Vascular Plug
Manufacturer: MicroVention Inc.
Device Classification Name: device, vascular, for promoting embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 06/24/2019
Decision Date: 03/20/2020
Regulation Medical Specialty: Cardiovascular
- 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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