FDA 510(k) clearance · back to tracker

14F Duo-Flow® Side X Side Double Lumen Catheter

Medical Components, Inc. cleared K250836 on 2025-08-12, decision: substantially equivalent

K-number

K250836

Sponsor

Medical Components, Inc.

Device

14F Duo-Flow® Side X Side Double Lumen Catheter

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-08-12

Product code

MPB

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5540

Official FDA record

Open K250836on 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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Raw record →

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.