510(k) K163399
K163399 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Tria Firm Ureteral Stent". The FDA issued a decision of Substantially Equivalent on Jun 22, 2017. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 22, 2017
- Date Received
- Dec 5, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stent, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.4620
- Review Panel
- GU
- Submission Type
- 510(k)