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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 K113737
Device Name SUREFIRE GUIDE SHEATH
Applicant
Surefire Medical, Inc.
12415 SW 136 Ave.
Unit 3
Miami,  FL  33186
Applicant Contact MARIO ARBESU
Correspondent
Surefire Medical, Inc.
12415 SW 136 Ave.
Unit 3
Miami,  FL  33186
Correspondent Contact MARIO ARBESU
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/20/2011
Decision Date 02/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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