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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, Diagnostic
510(k) Number K910259
Device Name SCHNEIDER MAGNARAIL PROBING CATHETER
Applicant
Schneider Intl., Ltd.
5905 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact HOWARD WITTELS
Correspondent
Schneider Intl., Ltd.
5905 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact HOWARD WITTELS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/22/1991
Decision Date 04/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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