Device Classification Name |
catheter, intravascular, diagnostic |
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---|---|---|---|---|
510(k) Number | K992142 | |||
Device Name | SCIMED ANGIOGRAPHIC CATHETERS | |||
Applicant |
|
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Applicant Contact | melanie raska | |||
Correspondent |
|
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Correspodent Contact | melanie raska | |||
Regulation Number | 870.1200 | |||
Classification Product Code |
|
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Date Received | 06/24/1999 | |||
Decision Date | 07/21/1999 | |||
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 |