K243704
- 510(k) number
- K243704
- Device name
- Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
- Applicant
- Brosmed Medical Co., Ltd. CN
- Product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Decision date
- 2025-02-27
- Date received
- 2024-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243704.pdf
Official FDA record: K243704
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.