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FDA 510(k), K080863, TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
FDA 510(k), K080863, TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
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510(K) Number: K080863
Device Name: TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
Manufacturer: MICROVENTION, INC.
Device Classification Name: wire, guide, catheter
Regulation Number: 870.1330
Classification Product Code: DQX
Date Received: 03/28/2008
Decision Date: 04/17/2008
Regulation Medical Specialty: Cardiovascular
Device Name: TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
Manufacturer: MICROVENTION, INC.
Device Classification Name: wire, guide, catheter
Regulation Number: 870.1330
Classification Product Code: DQX
Date Received: 03/28/2008
Decision Date: 04/17/2008
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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