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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 K905139
Device Name CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER
Applicant
Cathlab Corp.
17991 Fitch
Irvine,  CA  92714
Applicant Contact DANIEL LUCAS
Correspondent
Cathlab Corp.
17991 Fitch
Irvine,  CA  92714
Correspondent Contact DANIEL LUCAS
Regulation Number870.5150
Classification Product Code
DXE  
Date Received11/09/1990
Decision Date 02/25/1991
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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