K Number
K960310Device Name
EPIC INTRODUCER SHEATHManufacturer
Date Cleared
1996-02-07
(16 days)
Product Code
Regulation Number
870.1340Type
TraditionalPanel
CVReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).