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FDA 510(k), K200547, Traxcess 14 SELECT Guidewire
FDA 510(k), K200547, Traxcess 14 SELECT Guidewire
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510(K) Number: K200547
Device Name: Traxcess 14 SELECT Guidewire
Manufacturer: MicroVention Inc.
Device Classification Name: guide, wire, catheter, neurovasculature
Regulation Number: 870.1330
Classification Product Code: MOF
Date Received: 03/03/2020
Decision Date: 04/16/2020
Regulation Medical Specialty: Cardiovascular
Device Name: Traxcess 14 SELECT Guidewire
Manufacturer: MicroVention Inc.
Device Classification Name: guide, wire, catheter, neurovasculature
Regulation Number: 870.1330
Classification Product Code: MOF
Date Received: 03/03/2020
Decision Date: 04/16/2020
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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