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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 K093647
Device Name TRAXCESS DOCKING WIRE
Applicant
MICROVENTION, INC.
1311 VALENCIA AVE
TUSTIN,  CA  92780
Applicant Contact Naomi Gong
Correspondent
MICROVENTION, INC.
1311 VALENCIA AVE
TUSTIN,  CA  92780
Correspondent Contact Naomi Gong
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/25/2009
Decision Date 02/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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