FDA 510(k) clearance · back to tracker

SAT CenterFlow Molding Balloon Catheter (IN20-00313)

Strait Access Technologies Holdings cleared K243184 on 2025-06-25, decision: substantially equivalent

K-number

K243184

Sponsor

Strait Access Technologies Holdings

Device

SAT CenterFlow Molding Balloon Catheter (IN20-00313)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-06-25

Product code

DQY

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1250

Official FDA record

Open K243184on 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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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

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