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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 K230263
Device Name Finesse™ Injectable PTA Balloon Dilatation Catheter
Applicant
Summa Therapeutics, LLC
225 Dyer St., 2nd Floor
Providence,  RI  02903
Applicant Contact Timothy Murphy
Correspondent
Caraballo Consulting
11037 Bitternut Hickory Ln.
Boynton Beach,  FL  33437
Correspondent Contact Elena Jugo
Regulation Number870.1250
Classification Product Code
LIT  
Date Received01/31/2023
Decision Date 05/26/2023
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
Recalls CDRH Recalls
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