MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 by MEDTRONIC VASCULAR | FDA 510(k) Summary

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K Number

Device Name

MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254

Manufacturer

MEDTRONIC VASCULAR

Date Cleared

2001-04-05

(10 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

Intended Use

Device Description

AI/ML Overview

Summary

Regulation Number and Section

§ 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).