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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Occluder, Catheter Tip
510(k) Number K910916
Device Name CATHLAB SILICONE OCCLUSION BALLOON CATHETER
Applicant
Cathlab Corp.
17991 Fitch
Irvine,  CA  92714
Applicant Contact DANIEL R LUCAS
Correspondent
Cathlab Corp.
17991 Fitch
Irvine,  CA  92714
Correspondent Contact DANIEL R LUCAS
Regulation Number870.1370
Classification Product Code
DQT  
Date Received03/05/1991
Decision Date 06/24/1991
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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