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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K121677
Device Name SUREFIRE HI-FLOW MICROCATHETER
Applicant
SUREFIRE MEDICAL, INC.
12415 SW 136 AVENUE
UNIT 3
MIAMI,  FL  33186
Applicant Contact MARIO ARBESU
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/07/2012
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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