Firefighter Pro PTCA Balloon Catheter— 510(k) K252116
Substantially EquivalentShanghai MicroPort Medical (Group) Co., Ltd.
FDA 510(k) clearance K252116 for Firefighter Pro PTCA Balloon Catheter, Substantially Equivalent on 2026-04-07. Applicant: Shanghai MicroPort Medical (Group) Co., Ltd.. Device class: 2.
Summary
Shanghai MicroPort Medical (Group)'s Firefighter Pro PTCA Balloon Catheter is filed under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous).
Class II, 21 CFR 870.5100. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Shanghai MicroPort Medical filed from Shanghai, China. The record shows 274 calendar days from receipt to decision (July 7, 2025 to April 7, 2026).
Clearance details
- Applicant
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Product code
- Product code LOX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code LOX
view allMore clearances from Shanghai MicroPort Medical (Group) Co., Ltd.
view allAdverse events under product code LOX
product code LOX- Death
- 190
- Injury
- 1,498
- Malfunction
- 9,670
- Total
- 11,358
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.