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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 K010497
Device Name SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
Applicant
Micro Therapeutics, Inc.
2 Goodyear
Irvine,  CA  92618
Applicant Contact EBEN GORDON
Correspondent
Micro Therapeutics, Inc.
2 Goodyear
Irvine,  CA  92618
Correspondent Contact EBEN GORDON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/21/2001
Decision Date 03/22/2001
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
Recalls CDRH Recalls
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