FDA 510(k), K122316, AZUR DETACHABLE 35

FDA 510(k), K122316, AZUR DETACHABLE 35

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510(K) Number: K122316
Device Name: AZUR DETACHABLE 35
Manufacturer: MICROVENTION, INC.
Device Classification Name: device, vascular, for promoting embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 08/01/2012
Decision Date: 08/29/2012
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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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