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FDA 510(k), K051504, SPYSCOPE ACCESS AND DELIVERY CATHETER
FDA 510(k), K051504, SPYSCOPE ACCESS AND DELIVERY CATHETER
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510(K) Number: K051504
Device Name: SPYSCOPE ACCESS AND DELIVERY CATHETER
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: endoscopic access overtube, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FED
Date Received: 06/07/2005
Decision Date: 06/16/2005
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SPYSCOPE ACCESS AND DELIVERY CATHETER
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: endoscopic access overtube, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FED
Date Received: 06/07/2005
Decision Date: 06/16/2005
Regulation Medical Specialty: Gastroenterology/Urology
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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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