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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 K121385
Device Name VECTOR
Applicant
R4 VASCULAR, INC.
7550 MERIDIAN CIRCLE
SUITE 150
MAPLE GROVE,  MN  55369
Applicant Contact MICHAEL HOCH
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received05/08/2012
Decision Date 06/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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