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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 K192907
Device Name Advocate PTA Catheter
Applicant
Merit Medical Systems, Inc.
Parkmore Business Park W.
Galway,  IE N-A
Applicant Contact Mark Mullaney
Correspondent
Merit Medical Systems, Inc.
Parkmore Business Park W.
Galway,  IE N-A
Correspondent Contact Michael O'Sullivan
Regulation Number870.1250
Classification Product Code
LIT  
Date Received10/15/2019
Decision Date 11/26/2019
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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