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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 K002212
Device Name MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
Applicant
Micro Therapeutics, Inc.
2 Goodyear
Irvine,  CA  92618
Applicant Contact MARIBELLE AGUINALDO
Correspondent
Micro Therapeutics, Inc.
2 Goodyear
Irvine,  CA  92618
Correspondent Contact MARIBELLE AGUINALDO
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/21/2000
Decision Date 08/03/2000
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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