510(k) K130804
K130804 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "UROMAX ULTRA BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on May 22, 2013. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2013
- Date Received
- March 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Catheter, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.5470
- Review Panel
- GU
- Submission Type