510(k) K153655
K153655 is an FDA 510(k) premarket notification submitted by Potrero Medical, Inc. for the device "Accuryn Monitoring System". The FDA issued a decision of Substantially Equivalent (kit) on April 15, 2016. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Potrero Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- April 15, 2016
- Date Received
- December 21, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Retention Type, Balloon
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type