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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K982136
Device Name JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
Applicant
Schiff & Co.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ANNE M CESARIO
Correspondent
Schiff & Co.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ANNE M CESARIO
Regulation Number870.4400
Classification Product Code
DTN  
Date Received06/17/1998
Decision Date 03/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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