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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K100921
Device Name ADMIRAL XTREME PTA BALLOON DILATATION CATHETER
Applicant
Invatec S.P.A.
3101 Emrick Blvd.
Bethlehem,  PA  18020
Applicant Contact JOHN CLAY
Correspondent
Invatec S.P.A.
3101 Emrick Blvd.
Bethlehem,  PA  18020
Correspondent Contact JOHN CLAY
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received04/02/2010
Decision Date 04/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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