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FDA 510(k)

INCIRCLE BI-POLAR RF ABLATION SYSTEM

K-Number: K070711 · 2007-04-24

ApplicantRfa Medical, Inc.
Decision Date2007-04-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INCIRCLE BI-POLAR RF ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rfa Medical, Inc.. It received FDA 510(k) clearance on 2007-04-24 under 510(k) number K070711. 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 INCIRCLE BI-POLAR RF ABLATION SYSTEM?

INCIRCLE BI-POLAR RF ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-24. The listed applicant is Rfa Medical, Inc.. The 510(k) number is K070711.

When did INCIRCLE BI-POLAR RF ABLATION SYSTEM receive FDA 510(k) clearance?

INCIRCLE BI-POLAR RF ABLATION SYSTEM received FDA 510(k) clearance on 2007-04-24, under 510(k) number K070711.

Who is the listed applicant for INCIRCLE BI-POLAR RF ABLATION SYSTEM?

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

What is the FDA product code for INCIRCLE BI-POLAR RF ABLATION SYSTEM?

The FDA product code for INCIRCLE BI-POLAR RF ABLATION SYSTEM 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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