Device Classification Name |
Catheter, Electrode Recording, Or Probe, Electrode Recording
|
510(k) Number |
K150631 |
Device Name |
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter |
Applicant |
St. Jude Medical |
14901 De Veau Place |
Minnetonka,
MN
55345 -2126
|
|
Applicant Contact |
Harlan Jones |
Correspondent |
St. Jude Medical |
14901 De Veau Place |
Minnetonka,
MN
55345 -2126
|
|
Correspondent Contact |
Harlan Jones |
Regulation Number | 870.1220
|
Classification Product Code |
|
Date Received | 03/11/2015 |
Decision Date | 04/01/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|