Device Classification Name |
wire, guide, catheter |
|||
---|---|---|---|---|
510(k) Number | K030019 | |||
Device Name | MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE | |||
Original Applicant |
|
|||
Original Contact | kristine m teich | |||
Regulation Number | 870.1330 | |||
Classification Product Code |
|
|||
Date Received | 01/03/2003 | |||
Decision Date | 01/24/2003 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Cardiovascular |
|||
510k Review Panel |
Cardiovascular |
|||
summary |
summary |
|||
Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |