FDA 510(k)

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter

N.º K: K221832 · 2022-08-22

Fecha de decisión2022-08-22

Código de productoLIT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cordis US Corp. It received FDA 510(k) clearance on 2022-08-22 under 510(k) number K221832. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter?

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-08-22. The listed applicant is Cordis US Corp. The 510(k) number is K221832.

When did SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter receive FDA 510(k) clearance?

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter received FDA 510(k) clearance on 2022-08-22, under 510(k) number K221832.

Who is the listed applicant for SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter?

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

What is the FDA product code for SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter?

The FDA product code for SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter is LIT.

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Fuente oficial

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