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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 K172033
Device Name Pirouette High Pressure (HP)
Applicant
Arravasc, Ltd.
2 Ballybrit Business Park
Galway,  IE h91dt7c
Applicant Contact Carmel Doherty
Correspondent
Arravasc, Ltd.
2 Ballybrit Business Park
Galway,  IE h91dt7c
Correspondent Contact Carmel Doherty
Regulation Number870.1250
Classification Product Code
LIT  
Date Received07/05/2017
Decision Date 08/31/2017
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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