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K Number
K241740
Device Name
Finesse Injectable™ PTA Balloon Dilatation Catheter
Manufacturer
Summa Therapeutics
Date Cleared
2024-07-16

(29 days)

Product Code
LIT
Regulation Number
870.1250
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).