510(k) K173533
K173533 is an FDA 510(k) premarket notification submitted by Poiesis Medical, LLC for the device "Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter". The FDA issued a decision of Substantially Equivalent on Mar 29, 2018. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 29, 2018
- Date Received
- Nov 15, 2017
- 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
- 510(k)