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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Infusion, Intravascular, Electronic
510(k) Number K870317
Device Name IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280
Applicant
Y
10300 Campus Pt. Dr.
San Diego,  CA  92121
Applicant Contact ROBERT J BARD
Correspondent
Y
10300 Campus Pt. Dr.
San Diego,  CA  92121
Correspondent Contact ROBERT J BARD
Regulation Number880.5725
Classification Product Code
LDR  
Date Received01/28/1987
Decision Date 04/03/1987
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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