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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K150865
Device Name Metacross RX PTA Balloon Dilitation Catheter
Applicant
KANEKA Corporation
1-12-32, Akasaka, Minato-Ku
Tokyo,  JP
Applicant Contact Toshihiko Motomine
Correspondent
Quintiles Consulting
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Correspondent Contact Christopher M Sloan
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/01/2015
Decision Date 08/03/2015
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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