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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 N.W. 57TH CT.
MIAMI LAKES,  FL  33014
Applicant Contact MARTINE D SCHNEIDER
Correspondent
CORDIS NEUROVASCULAR, INC.
14000 N.W. 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
Recalls CDRH Recalls
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