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K Number
K000366

Validate with FDA (Live)

Device Name
FIXATION STYLETS, MODELS 335-287 AND 335-288
Manufacturer
ACCUFIX RESEARCH INSTITUTE
Date Cleared
2000-04-14

(70 days)

Product Code
DRB
Regulation Number
870.1380
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
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).