Device Classification Name |
introducer, catheter |
|||
---|---|---|---|---|
510(k) Number | K121185 | |||
Device Name | EDWARDS PERCUTANEOUS SHEATH INTRODUCER | |||
Applicant |
|
|||
Applicant Contact | spencer walker | |||
Correspondent |
|
|||
Correspodent Contact | spencer walker | |||
Regulation Number | 870.1340 | |||
Classification Product Code |
|
|||
Date Received | 04/18/2012 | |||
Decision Date | 08/22/2012 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Cardiovascular |
|||
510k Review Panel |
Cardiovascular |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |