Polaris RF Ablation System

Generator, Lesion, Radiofrequency

Baylis Medical Company Inc.

The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Polaris Rf Ablation System.

Pre-market Notification Details

• Device ID: K181864
• 510k Number: K181864
• Device Name: Polaris RF Ablation System
• Classification: Generator, Lesion, Radiofrequency
• Applicant: Baylis Medical Company Inc. 2775 Matheson Blvd. East Mississauga, CA L4w 4p7
• Contact: May Tsai
• Correspondent: May Tsai; Baylis Medical Company Inc. 2775 Matheson Blvd. East Mississauga, CA L4w 4p7
• Product Code: GXD
• CFR Regulation Number: 882.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-12
• Decision Date: 2019-01-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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