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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 K983003
Device Name 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
Applicant
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes,  FL  33014
Applicant Contact MARTINE D SCHNEIDER
Correspondent
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes,  FL  33014
Correspondent Contact MARTINE D SCHNEIDER
Regulation Number870.1210
Classification Product Code
KRA  
Date Received08/28/1998
Decision Date 09/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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