FDA 510(k)

ULTRASCORE Focused Force PTA Balloon

N.º K: K172571 · 2017-09-22

Fecha de decisión2017-09-22

Código de productoPNO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

ULTRASCORE Focused Force PTA Balloon is the device name listed in this FDA 510(k) record. The listed applicant is C. R. Bard. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K172571. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ULTRASCORE Focused Force PTA Balloon?

ULTRASCORE Focused Force PTA Balloon is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is C. R. Bard. The 510(k) number is K172571.

When did ULTRASCORE Focused Force PTA Balloon receive FDA 510(k) clearance?

ULTRASCORE Focused Force PTA Balloon received FDA 510(k) clearance on 2017-09-22, under 510(k) number K172571.

Who is the listed applicant for ULTRASCORE Focused Force PTA Balloon?

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

What is the FDA product code for ULTRASCORE Focused Force PTA Balloon?

The FDA product code for ULTRASCORE Focused Force PTA Balloon is PNO.

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Dispositivos relacionados (Código: PNO)

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Fuente oficial

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