Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K142239 |
Device Name |
CPS Direct MediGuide Enabled outer catheter |
Applicant |
St. Jude Medical |
15900 Valley View Court |
Sylmar,
CA
91342
|
|
Applicant Contact |
Geena George |
Correspondent |
St. Jude Medical |
15900 Valley View Court |
Sylmar,
CA
91342
|
|
Correspondent Contact |
Zachary Price |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 08/13/2014 |
Decision Date | 12/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|