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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 K936282
Device Name TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)
Applicant
Cordis Neurovascular, Inc.
14740 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact MARLENE WRIGHT
Correspondent
Cordis Neurovascular, Inc.
14740 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact MARLENE WRIGHT
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/30/1993
Decision Date 07/18/1994
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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