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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, Long-Term Greater Than 30 Days
510(k) Number K861563
Device Name VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT
Applicant
Vitaphore Corp.
Burditt, Bowles & Radzius
333 Market St., Suite 2220
San Francisco,  CA  94105
Applicant Contact CHARLES L MORIN
Correspondent
Vitaphore Corp.
Burditt, Bowles & Radzius
333 Market St., Suite 2220
San Francisco,  CA  94105
Correspondent Contact CHARLES L MORIN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received04/25/1986
Decision Date 08/27/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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