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FDA 510(k)

Pacific Plus PTA Catheter

K-Number: K202800 · 2020-11-18

ApplicantMedtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)
Decision Date2020-11-18
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pacific Plus PTA Catheter is a medical device manufactured by Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC). It received FDA 510(k) clearance on 2020-11-18 under approval number K202800. 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 Pacific Plus PTA Catheter?

Pacific Plus PTA Catheter is a medical device that received FDA 510(k) clearance on 2020-11-18. It is manufactured by Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC). The 510(k) number is K202800.

When was Pacific Plus PTA Catheter approved by the FDA?

Pacific Plus PTA Catheter received FDA 510(k) clearance on 2020-11-18, under approval number K202800.

What company makes Pacific Plus PTA Catheter?

Pacific Plus PTA Catheter is manufactured by Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC).

What is the FDA product code for Pacific Plus PTA Catheter?

The FDA product code for Pacific Plus PTA Catheter is LIT.

Related Devices (Code: 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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