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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 K141707
Device Name ULTRASKIN HYDROPHILIC GUIDE WIRE
Applicant
Lepu Medical Technology (Beijing) Co., Ltd.
1531 Felton Rd.
South Euclid,  OH  44121
Applicant Contact ARTHUR GODDARD
Correspondent
Lepu Medical Technology (Beijing) Co., Ltd.
1531 Felton Rd.
South Euclid,  OH  44121
Correspondent Contact ARTHUR GODDARD
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/24/2014
Decision Date 01/21/2015
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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