FDA 510(k)

PressureWire X

N.º K: K180558 · 2018-03-28

SolicitanteSt. Jude Medical (Now Part of Abbott Medical)

Fecha de decisión2018-03-28

Código de productoDXO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

PressureWire X is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical (Now Part of Abbott Medical). It received FDA 510(k) clearance on 2018-03-28 under 510(k) number K180558. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PressureWire X?

PressureWire X is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is St. Jude Medical (Now Part of Abbott Medical). The 510(k) number is K180558.

When did PressureWire X receive FDA 510(k) clearance?

PressureWire X received FDA 510(k) clearance on 2018-03-28, under 510(k) number K180558.

Who is the listed applicant for PressureWire X?

The FDA 510(k) record lists St. Jude Medical (Now Part of Abbott Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PressureWire X?

The FDA product code for PressureWire X is DXO.

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Fuente oficial

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