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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wire, guide, catheter
510(k) Number K122506
Device Name SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
Original Applicant
SUREFIRE MEDICAL, INC
12415 sw 136 avenue
unit 3
miami,  FL  33186
Original Contact mario arbesu
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/17/2012
Decision Date 09/17/2012
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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