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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 K030062
Device Name ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0
Applicant
Avantec Vascular Corp.
1049 Kiel Ct.
Sunnyvale,  CA  94089
Applicant Contact JAMES M SHY
Correspondent
Avantec Vascular Corp.
1049 Kiel Ct.
Sunnyvale,  CA  94089
Correspondent Contact JAMES M SHY
Regulation Number870.1250
Classification Product Code
LIT  
Date Received01/07/2003
Decision Date 04/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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