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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 K954949
Device Name TRANSIT INFUSION CATHETER WITH SIDEHOLES
Applicant
Cordis Neurovascular, Inc.
14740 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact MARLENE W VALENTI
Correspondent
Cordis Neurovascular, Inc.
14740 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact MARLENE W VALENTI
Regulation Number870.1210
Classification Product Code
KRA  
Date Received10/30/1995
Decision Date 12/22/1995
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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