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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 K950047
Device Name SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER
Applicant
Isomedix Operations, Inc.
1880 Industrial Dr.
Libertyville,  IL  60048
Correspondent
Isomedix Operations, Inc.
1880 Industrial Dr.
Libertyville,  IL  60048
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/05/1995
Decision Date 04/05/1995
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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