FDA 510(k), K060057, PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
FDA 510(k), K060057, PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
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510(K) Number: K060057
Device Name: PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
Manufacturer: EV3 INC.
Device Classification Name: stents, drains and dilators for the biliary ducts
Regulation Number: 876.5010
Classification Product Code: FGE
Date Received: 01/09/2006
Decision Date: 03/08/2006
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
Manufacturer: EV3 INC.
Device Classification Name: stents, drains and dilators for the biliary ducts
Regulation Number: 876.5010
Classification Product Code: FGE
Date Received: 01/09/2006
Decision Date: 03/08/2006
Regulation Medical Specialty: Gastroenterology/Urology
- 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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