Device Classification Name |
catheter, angioplasty, peripheral, transluminal |
|||
---|---|---|---|---|
510(k) Number | K991811 | |||
Device Name | CORDIS MAXI DS PTA BALLOON CATHETER | |||
Applicant |
|
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Applicant Contact | ariel mactavish | |||
Correspondent |
|
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Correspodent Contact | ariel mactavish | |||
Regulation Number | 870.1250 | |||
Classification Product Code |
|
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Date Received | 05/27/1999 | |||
Decision Date | 06/15/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Cardiovascular |
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510k Review Panel |
Cardiovascular |
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summary |
summary |
|||
Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |