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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K001033
Device Name AGILITY STEERABLE GUIDEWIRE
Applicant
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes,  FL  33014
Applicant Contact MARITZA CELAYA
Correspondent
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes,  FL  33014
Correspondent Contact MARITZA CELAYA
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/31/2000
Decision Date 04/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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