FDA 510(k)

Solución AirSeal® dV - Capuchón de cánula AirSeal® y Conjunto de Tubo Filtrado Bifurcado AirSeal®

N.º K: K211104 · 2021-08-19

Fecha de decisión2021-08-19

Código de productoHIF

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K211104. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set?

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Conmed Corporation. The 510(k) number is K211104.

When did AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set receive FDA 510(k) clearance?

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set received FDA 510(k) clearance on 2021-08-19, under 510(k) number K211104.

Who is the listed applicant for AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set?

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

What is the FDA product code for AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set?

The FDA product code for AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set is HIF.

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Fuente oficial

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