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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 K932218
Device Name CARDIAC CATH OR ANGIOGRAPHIC TRAYS
Applicant
Associated Medical Products Co.
3250 Gorham Ave.
St. Louis Park,  MN  55426
Applicant Contact SCOTT WEISS
Correspondent
Associated Medical Products Co.
3250 Gorham Ave.
St. Louis Park,  MN  55426
Correspondent Contact SCOTT WEISS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/07/1993
Decision Date 08/27/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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