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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K945461
Device Name PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)
Applicant
Medtronics Interventional Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact JOSEPH O MAGLIOZZI
Correspondent
Medtronics Interventional Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact JOSEPH O MAGLIOZZI
Regulation Number870.4290
Classification Product Code
DTL  
Date Received11/07/1994
Decision Date 02/03/1995
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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