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Polaris RF Ablation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181864
510(k) Type
Traditional
Applicant
Baylis Medical Company Inc.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
1/2/2019
Days to Decision
174 days
Submission Type
Summary

Polaris RF Ablation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181864
510(k) Type
Traditional
Applicant
Baylis Medical Company Inc.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
1/2/2019
Days to Decision
174 days
Submission Type
Summary