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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 K080863
Device Name TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
Applicant
MicroVention, Inc.
75 Columbia
Suite A
Aliso Viejo,  CA  92656 -1408
Applicant Contact KEVIN E DALY
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/28/2008
Decision Date 04/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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