510(k) K172571
K172571 is an FDA 510(k) premarket notification submitted by C. R. Bard for the device "ULTRASCORE Focused Force PTA Balloon". The FDA issued a decision of Substantially Equivalent on September 22, 2017. The device falls under product code PNO (Catheter, Percutaneous, Cutting/Scoring), a Class II device regulated under 21 CFR 870.1250. C. R. Bard has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 2017
- Date Received
- August 28, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous, Cutting/Scoring
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material