FDA 510(k)

NAMIC Dilator and Sheath

Número K: K253526 · 2026-07-29

Data da decisão2026-07-29

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

NAMIC Dilator and Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2026-07-29 under 510(k) number K253526. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NAMIC Dilator and Sheath?

NAMIC Dilator and Sheath is a medical device that received FDA 510(k) clearance on 2026-07-29. The listed applicant is Medline Industries, LP. The 510(k) number is K253526.

When did NAMIC Dilator and Sheath receive FDA 510(k) clearance?

NAMIC Dilator and Sheath received FDA 510(k) clearance on 2026-07-29, under 510(k) number K253526.

Who is the listed applicant for NAMIC Dilator and Sheath?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAMIC Dilator and Sheath?

The FDA product code for NAMIC Dilator and Sheath is DYB.

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Fonte oficial

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