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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 K072798
Device Name VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
Applicant
ABBOTT VASCULAR-VASCULAR SOLUTIONS
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Applicant Contact DANIELLE M TAYLOR
Correspondent
ABBOTT VASCULAR-VASCULAR SOLUTIONS
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Correspondent Contact DANIELLE M TAYLOR
Regulation Number870.1250
Classification Product Code
LIT  
Date Received10/01/2007
Decision Date 01/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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