FDA 510(k)

pilot TLS

Numéro K : K241587 · 2025-02-26

Date de décision2025-02-26

Code produitLJS

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

pilot TLS is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Corporation. It received FDA 510(k) clearance on 2025-02-26 under 510(k) number K241587. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the pilot TLS?

pilot TLS is a medical device that received FDA 510(k) clearance on 2025-02-26. The listed applicant is Vygon Corporation. The 510(k) number is K241587.

When did pilot TLS receive FDA 510(k) clearance?

pilot TLS received FDA 510(k) clearance on 2025-02-26, under 510(k) number K241587.

Who is the listed applicant for pilot TLS?

The FDA 510(k) record lists Vygon Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for pilot TLS?

The FDA product code for pilot TLS is LJS.

Essais cliniques associés

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Dispositifs connexes (Code : LJS)

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Source officielle

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