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FDA 510(k), K811384, HEMASITE VASCULAR ACCESS SHUNT
FDA 510(k), K811384, HEMASITE VASCULAR ACCESS SHUNT
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510(K) Number: K811384
Device Name: HEMASITE VASCULAR ACCESS SHUNT
Manufacturer: RENAL SYSTEMS, INC.
Device Classification Name: cannula, a-v shunt
Regulation Number: 876.5540
Classification Product Code: FIQ
Date Received: 05/19/1981
Decision Date: 07/31/1981
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: HEMASITE VASCULAR ACCESS SHUNT
Manufacturer: RENAL SYSTEMS, INC.
Device Classification Name: cannula, a-v shunt
Regulation Number: 876.5540
Classification Product Code: FIQ
Date Received: 05/19/1981
Decision Date: 07/31/1981
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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