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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K881455
Device Name EMBOLECTOMY CATHETER(MODIFIED)
Applicant
Cathlab Corp.
2695 Dow Ave.
Tustin,  CA  92680
Applicant Contact SATTAR SAUDAGAR
Correspondent
Cathlab Corp.
2695 Dow Ave.
Tustin,  CA  92680
Correspondent Contact SATTAR SAUDAGAR
Regulation Number870.5150
Classification Product Code
DXE  
Date Received04/06/1988
Decision Date 06/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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