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FDA 510(k)

Stratus Infusion Catheter

N.º K: K222185 · 2023-04-13

SolicitanteIntervene, Inc.
Fecha de decisión2023-04-13
Código de productoNPG
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Stratus Infusion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Intervene, Inc.. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K222185. The device is classified under product code NPG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Stratus Infusion Catheter?

Stratus Infusion Catheter is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Intervene, Inc.. The 510(k) number is K222185.

When did Stratus Infusion Catheter receive FDA 510(k) clearance?

Stratus Infusion Catheter received FDA 510(k) clearance on 2023-04-13, under 510(k) number K222185.

Who is the listed applicant for Stratus Infusion Catheter?

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

What is the FDA product code for Stratus Infusion Catheter?

The FDA product code for Stratus Infusion Catheter is NPG.

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Fuente oficial

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