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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 K931560
Device Name CARDIAC CATHETERIZATION TRAY
Applicant
Clinipad Corp.
66 High St.
P.O. Box 387
Guilford,  CT  06437
Applicant Contact PATRICIA STAWARZ
Correspondent
Clinipad Corp.
66 High St.
P.O. Box 387
Guilford,  CT  06437
Correspondent Contact PATRICIA STAWARZ
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/30/1993
Decision Date 07/11/1994
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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