510(k) K243704
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter by
Brosmed Medical Co., Ltd.
— Product Code LIT
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2025
- Date Received
- November 29, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type