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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K852479
Device Name PULMONARY VEIN CLAMP
Applicant
None
7930 Frost St.
Suite 305
San Diego,  CA  92123
Applicant Contact DAILY, M.D.
Correspondent
None
7930 Frost St.
Suite 305
San Diego,  CA  92123
Correspondent Contact DAILY, M.D.
Regulation Number870.4450
Classification Product Code
DXC  
Date Received06/11/1985
Decision Date 08/09/1985
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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