FDA 510(k), K151840, Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
FDA 510(k), K151840, Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
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510(K) Number: K151840
Device Name: Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
Manufacturer: Boston Scientific Corporation
Device Classification Name: wire, guide, catheter
Regulation Number: 870.1330
Classification Product Code: DQX
Date Received: 07/06/2015
Decision Date: 12/16/2015
Regulation Medical Specialty: Cardiovascular
Device Name: Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
Manufacturer: Boston Scientific Corporation
Device Classification Name: wire, guide, catheter
Regulation Number: 870.1330
Classification Product Code: DQX
Date Received: 07/06/2015
Decision Date: 12/16/2015
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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