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FDA 510(k)

CoreCath 2.7S

K-Number: K170296 · 2017-03-20

ApplicantMedtronic Advanced Energy
Decision Date2017-03-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CoreCath 2.7S is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Advanced Energy. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K170296. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoreCath 2.7S?

CoreCath 2.7S is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K170296.

When did CoreCath 2.7S receive FDA 510(k) clearance?

CoreCath 2.7S received FDA 510(k) clearance on 2017-03-20, under 510(k) number K170296.

Who is the listed applicant for CoreCath 2.7S?

The FDA 510(k) record lists Medtronic Advanced Energy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoreCath 2.7S?

The FDA product code for CoreCath 2.7S is GEI.

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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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