Device Classification Name |
system, hypothermia, intravenous, cooling |
|||
---|---|---|---|---|
510(k) Number | K030421 | |||
Device Name | ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM | |||
Applicant |
|
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Applicant Contact | kenneth a collins | |||
Correspondent |
|
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Correspodent Contact | kenneth a collins | |||
Regulation Number | 870.5900 | |||
Classification Product Code |
|
|||
Date Received | 02/10/2003 | |||
Decision Date | 10/23/2003 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Cardiovascular |
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510k Review Panel |
General & Plastic Surgery |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |
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Recalls | CDRH Recalls |