FDA 510(k) clearance · back to tracker
Firefighter Pro PTCA Balloon Catheter
Shanghai MicroPort Medical (Group) Co., Ltd. cleared K252116 on 2026-04-07, decision: substantially equivalent
K-number
K252116
Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.
Device
Firefighter Pro PTCA Balloon Catheter
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-04-07
Product code
LOX
Advisory committee
Cardiovascular
Medical specialty
Cardiovascular
Regulation number
870.5100
Official FDA record
Open K252116on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.