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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K151153
Device Name Pirouette 018
Applicant
Arravasc Limited
2 Ballybrit Business Park
Galway,  IE
Applicant Contact MAIREAD MCCAFFREY
Correspondent
Qserve Group, Us, Inc.
P.O. Box 940
Charlestown,  NH  03603
Correspondent Contact Jan-Paul van Loon
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/30/2015
Decision Date 08/20/2015
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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