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K Number
K003535
Device Name
STYLET KIT, MODELS 6254,6282,6293
Manufacturer
MEDTRONIC VASCULAR
Date Cleared
2001-02-08

(84 days)

Product Code
DRB
Regulation Number
870.1380
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.1380 Catheter stylet.

(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).