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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, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K073471
Device Name VANTAGECATH INTRAVASCULAR CATHETER
Applicant
Advantage Medical Device
28241 Crown Valley Pkwy.
Suite 510
Laguna Niguel,  CA  92677
Applicant Contact James Smith
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact CASEY CONRY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/11/2007
Decision Date 04/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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