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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K220629
Device Name Emerge Monorail PTCA Dilatation Catheter
Applicant
Boston Scientific
Ballybrit Business Park, Ballybrit
Galway,  IE H91Y868
Applicant Contact Aoife O'Flaherty
Correspondent
Boston Scientific
Ballybrit Business Park, Ballybrit
Galway,  IE H91Y868
Correspondent Contact Aoife O'Flaherty
Regulation Number870.5100
Classification Product Code
LOX  
Date Received03/04/2022
Decision Date 03/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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