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FDA 510(k)

Empower RF Catheter

K-Number: K183240 · 2019-02-22

ApplicantBroncus Medical, Inc.
Decision Date2019-02-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Empower RF Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Broncus Medical, Inc.. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K183240. 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 Empower RF Catheter?

Empower RF Catheter is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Broncus Medical, Inc.. The 510(k) number is K183240.

When did Empower RF Catheter receive FDA 510(k) clearance?

Empower RF Catheter received FDA 510(k) clearance on 2019-02-22, under 510(k) number K183240.

Who is the listed applicant for Empower RF Catheter?

The FDA 510(k) record lists Broncus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Empower RF Catheter?

The FDA product code for Empower RF Catheter is GEI.

Other records listing Broncus Medical, Inc. as applicant

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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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