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FDA 510(k)

EverCrossTM 0.035 OTW PTA Dilatation Catheter

Número K: K190753 · 2019-04-23

RequerenteMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)
Data da decisão2019-04-23
Código do produtoLIT
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

EverCrossTM 0.035 OTW PTA Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.). It received FDA 510(k) clearance on 2019-04-23 under 510(k) number K190753. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EverCrossTM 0.035 OTW PTA Dilatation Catheter?

EverCrossTM 0.035 OTW PTA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2019-04-23. The listed applicant is Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.). The 510(k) number is K190753.

When did EverCrossTM 0.035 OTW PTA Dilatation Catheter receive FDA 510(k) clearance?

EverCrossTM 0.035 OTW PTA Dilatation Catheter received FDA 510(k) clearance on 2019-04-23, under 510(k) number K190753.

Who is the listed applicant for EverCrossTM 0.035 OTW PTA Dilatation Catheter?

The FDA 510(k) record lists Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EverCrossTM 0.035 OTW PTA Dilatation Catheter?

The FDA product code for EverCrossTM 0.035 OTW PTA Dilatation Catheter is LIT.

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Dispositivos Relacionados (Código: LIT)

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Fonte oficial

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