510(k) K193181
K193181 is an FDA 510(k) premarket notification submitted by Cagent Vascular, LLC for the device "Serranator PTA Serration Balloon Catheter". The FDA issued a decision of Substantially Equivalent on April 15, 2020. The device falls under product code PNO (Catheter, Percutaneous, Cutting/Scoring), a Class II device regulated under 21 CFR 870.1250. Cagent Vascular, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2020
- Date Received
- November 18, 2019
- Clearance Type
- Traditional
- 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