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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 West
galway,  IE n-a
Applicant Contact mark mullaney
Correspondent
Merit Medical Systems Inc.
Parkmore Business Park West
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
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