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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Recording, Electrode, Reprocessed
510(k) Number K050763
Device Name VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
Applicant
Vanguard Medical Concepts, Inc.
5307 Great Oak Dr.
Lakeland,  FL  33815
Applicant Contact HEATHER CRAWFORD
Correspondent
Vanguard Medical Concepts, Inc.
5307 Great Oak Dr.
Lakeland,  FL  33815
Correspondent Contact HEATHER CRAWFORD
Regulation Number870.1220
Classification Product Code
NLH  
Date Received03/24/2005
Decision Date 06/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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