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K Number
K004025
Device Name
SPLITTABLE SHEATH INTRODUCER KIT
Manufacturer
THOMAS MEDICAL PRODUCTS, INC.
Date Cleared
2001-07-19

(204 days)

Product Code
DYB
Regulation Number
870.1340
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
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).