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FDA 510(k)

Polaris RF Ablation System

K-Number: K181864 · 2019-01-02

ApplicantBaylis Medical Company, Inc.
Decision Date2019-01-02
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Polaris RF Ablation System is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2019-01-02 under approval number K181864. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polaris RF Ablation System?

Polaris RF Ablation System is a medical device that received FDA 510(k) clearance on 2019-01-02. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K181864.

When was Polaris RF Ablation System approved by the FDA?

Polaris RF Ablation System received FDA 510(k) clearance on 2019-01-02, under approval number K181864.

What company makes Polaris RF Ablation System?

Polaris RF Ablation System is manufactured by Baylis Medical Company, Inc..

What is the FDA product code for Polaris RF Ablation System?

The FDA product code for Polaris RF Ablation System is GXD.

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Other Devices by Baylis Medical Company, Inc.

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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.

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