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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 K930982
Device Name ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE
Applicant
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact BARBARA RAMSEYER
Correspondent
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact BARBARA RAMSEYER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/25/1993
Decision Date 02/24/1994
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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