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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K945705
Device Name 5F ENVOY(TM) GUIDING CATHETER
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 Number870.1250
Classification Product Code
DQY  
Date Received11/08/1994
Decision Date 02/03/1995
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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