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K Number
K010906

Validate with FDA (Live)

Device Name
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
Manufacturer
MEDTRONIC VASCULAR
Date Cleared
2001-04-05

(10 days)

Product Code
DRB
Regulation Number
870.1380
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K063210
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).