Device Classification Name |
generator, lesion, radiofrequency
|
510(k) Number |
K181864 |
Device Name |
Polaris RF Ablation System |
Applicant |
Baylis Medical Company Inc. |
2775 Matheson Blvd. East |
Mississauga,
CA
L4W 4P7
|
|
Applicant Contact |
May Tsai |
Correspondent |
Baylis Medical Company Inc. |
2775 Matheson Blvd. East |
Mississauga,
CA
L4W 4P7
|
|
Correspondent Contact |
May Tsai |
Regulation Number | 882.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/12/2018 |
Decision Date | 01/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|