510(k) K241478
K241478 is an FDA 510(k) premarket notification submitted by Brosmed Medical Co., Ltd. for the device "Tri-Wedge PTA Scoring Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on October 22, 2024. The device falls under product code PNO (Catheter, Percutaneous, Cutting/Scoring), a Class II device regulated under 21 CFR 870.1250. Brosmed Medical Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2024
- Date Received
- May 24, 2024
- 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