FDA 510(k) clearance · back to tracker

NC PTA Balloon Dilatation Catheter

Kossel Medtech (Suzhou) Co., Ltd. cleared K254212 on 2026-09-16, decision: substantially equivalent

K-number

K254212

Sponsor

Kossel Medtech (Suzhou) Co., Ltd.

Device

NC PTA Balloon Dilatation Catheter

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-09-16

Product code

LIT

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1250

Official FDA record

Open K254212on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.