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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K081052
Device Name OCCLUSION BALLOON CATHETER, MODEL VENOS
Applicant
Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Applicant Contact MILA DOSKOCIL
Correspondent
Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Correspondent Contact MILA DOSKOCIL
Regulation Number870.1240
Classification Product Code
DYG  
Date Received04/14/2008
Decision Date 06/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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