FDA 510(k)

Catheter intravascular AccuCath Ace™

N.º K: K233106 · 2024-04-19

SolicitanteBard Access Systems, Inc. (C.R. Bard, Inc.)

Fecha de decisión2024-04-19

Código de productoFOZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

AccuCath Ace™ Intravascular Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc. (C.R. Bard, Inc.). It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K233106. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AccuCath Ace™ Intravascular Catheter?

AccuCath Ace™ Intravascular Catheter is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Bard Access Systems, Inc. (C.R. Bard, Inc.). The 510(k) number is K233106.

When did AccuCath Ace™ Intravascular Catheter receive FDA 510(k) clearance?

AccuCath Ace™ Intravascular Catheter received FDA 510(k) clearance on 2024-04-19, under 510(k) number K233106.

Who is the listed applicant for AccuCath Ace™ Intravascular Catheter?

The FDA 510(k) record lists Bard Access Systems, Inc. (C.R. Bard, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccuCath Ace™ Intravascular Catheter?

The FDA product code for AccuCath Ace™ Intravascular Catheter is FOZ.

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Fuente oficial

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