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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K974222
Device Name CES MASSTRANSIT INFUSION CATHETER
Applicant
Cordis Neurovascular, Inc.
14740 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact Lisa Wells
Correspondent
Cordis Neurovascular, Inc.
14740 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact Lisa Wells
Regulation Number870.1210
Classification Product Code
KRA  
Date Received11/12/1997
Decision Date 02/10/1998
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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