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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K891456
Device Name HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
Applicant
Baxter Healthcare Corp
7280 N. Caldwell
Niles,  IL  60648
Applicant Contact MORIZIO, R.N.
Correspondent
Baxter Healthcare Corp
7280 N. Caldwell
Niles,  IL  60648
Correspondent Contact MORIZIO, R.N.
Regulation Number882.5550
Classification Product Code
JXG  
Date Received03/15/1989
Decision Date 06/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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