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FDA 510(k)

EverCrossTM 0.035 OTW PTA Dilatation Catheter

K-Number: K190753 · 2019-04-23

ApplicantMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)
Decision Date2019-04-23
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.). The 510(k) number is K190753.

When was EverCrossTM 0.035 OTW PTA Dilatation Catheter approved by the FDA?

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

What company makes EverCrossTM 0.035 OTW PTA Dilatation Catheter?

EverCrossTM 0.035 OTW PTA Dilatation Catheter is manufactured by Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.).

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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