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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 K897184
Device Name 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS
Applicant
Cathlab Corp.
2695 Dow Ave.
Tustin,  CA  92680
Applicant Contact DANIEL R LUCAS
Correspondent
Cathlab Corp.
2695 Dow Ave.
Tustin,  CA  92680
Correspondent Contact DANIEL R LUCAS
Regulation Number870.5150
Classification Product Code
DXE  
Date Received12/28/1989
Decision Date 03/14/1990
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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