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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 K132545
Device Name MEDIVALVE ACWIRE
Applicant
Medivalve , Ltd.
93 Benefit St.
Providence,  RI  02904
Applicant Contact LEO BASTA
Correspondent
Medivalve , Ltd.
93 Benefit St.
Providence,  RI  02904
Correspondent Contact LEO BASTA
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/13/2013
Decision Date 11/08/2013
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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