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 a medical device manufactured by Broncus Medical, Inc.. It received FDA 510(k) clearance on 2019-02-22 under approval 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. It is manufactured by Broncus Medical, Inc.. The 510(k) number is K183240.
When was Empower RF Catheter approved by the FDA?
Empower RF Catheter received FDA 510(k) clearance on 2019-02-22, under approval number K183240.
What company makes Empower RF Catheter?
Empower RF Catheter is manufactured by Broncus Medical, Inc..
What is the FDA product code for Empower RF Catheter?
The FDA product code for Empower RF Catheter is GEI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.