K252116
- 510(k) number
- K252116
- Device name
- Firefighter Pro PTCA Balloon Catheter
- Applicant
- Shanghai MicroPort Medical (Group) Co., Ltd. CN
- Product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percut
- Decision date
- 2026-04-07
- Date received
- 2025-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K252116.pdf
Official FDA record: K252116
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.