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FDA 510(k), K153655, Accuryn Monitoring System
FDA 510(k), K153655, Accuryn Monitoring System
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510(K) Number: K153655
Device Name: Accuryn Monitoring System
Manufacturer: POTRERO MEDICAL, INC.
Device Classification Name: catheter, retention type, balloon
Regulation Number: 876.5130
Classification Product Code: EZL
Date Received: 12/21/2015
Decision Date: 04/15/2016
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Accuryn Monitoring System
Manufacturer: POTRERO MEDICAL, INC.
Device Classification Name: catheter, retention type, balloon
Regulation Number: 876.5130
Classification Product Code: EZL
Date Received: 12/21/2015
Decision Date: 04/15/2016
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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