Device Classification Name |
probe, radiofrequency lesion
|
510(k) Number |
K183177 |
Device Name |
Nitinol Thermocouple (TCN) Electrode |
Applicant |
Boston Scientific Corporation |
25155 Rye Canyon Loop |
Valencia,
CA
91355
|
|
Applicant Contact |
Adele Shoustal |
Correspondent |
Boston Scientific Corporation |
25155 Rye Canyon Loop |
Valencia,
CA
91355
|
|
Correspondent Contact |
Adele Shoustal |
Regulation Number | 882.4725
|
Classification Product Code |
|
Date Received | 11/16/2018 |
Decision Date | 03/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|