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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K897082
Device Name SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR
Applicant
Schneider Intl., Ltd.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Applicant Contact ROBERT L ULLEN
Correspondent
Schneider Intl., Ltd.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Correspondent Contact ROBERT L ULLEN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/20/1989
Decision Date 03/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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