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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K863337
Device Name CORDIPAK CARDIAC CATHETERIZATION PACK
Applicant
Angi-Pak Corp.
13780 SW 73 Ct.
Miami,  FL  33158
Applicant Contact STEWART FINCH
Correspondent
Angi-Pak Corp.
13780 SW 73 Ct.
Miami,  FL  33158
Correspondent Contact STEWART FINCH
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/28/1986
Decision Date 09/29/1986
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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