FDA 510(k)

PerQseal Introducers

N.º K: K252309 · 2025-10-23

Fecha de decisión2025-10-23

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

PerQseal Introducers is the device name listed in this FDA 510(k) record. The listed applicant is Vivasure Medical Limited. It received FDA 510(k) clearance on 2025-10-23 under 510(k) number K252309. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PerQseal Introducers?

PerQseal Introducers is a medical device that received FDA 510(k) clearance on 2025-10-23. The listed applicant is Vivasure Medical Limited. The 510(k) number is K252309.

When did PerQseal Introducers receive FDA 510(k) clearance?

PerQseal Introducers received FDA 510(k) clearance on 2025-10-23, under 510(k) number K252309.

Who is the listed applicant for PerQseal Introducers?

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

What is the FDA product code for PerQseal Introducers?

The FDA product code for PerQseal Introducers is DYB.

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Dispositivos relacionados (Código: DYB)

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Fuente oficial

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