FDA 510(k) clearance · back to tracker

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

Medtronic, Ireland cleared K251970 on 2026-01-17, decision: substantially equivalent

K-number

K251970

Sponsor

Medtronic, Ireland

Device

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-01-17

Product code

LOX

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.5100

Official FDA record

Open K251970on 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.