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K Number
K061958
Device Name
MEDTRONIC EXPORT XT CATHETER
Manufacturer
MEDTRONIC VASCULAR
Date Cleared
2006-09-05

(56 days)

Product Code
QEZ,DXE,KRA
Regulation Number
870.5150
Type
Special
Panel
CV
Reference & Predicate Devices
K040869
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Medtronic Export® XT Catheter is indicated for:

  • Removal/aspiration of embolic material (thrombus/debris) from vessels . of the arterial system, and
  • To subselectively infuse/deliver diagnostics or therapeutics agents with . or without vessel occlusion.
Device Description

The Medtronic Export XT Catheter is a dual lumen catheter used for the aspiration of thrombus and/or debris from a vascular site. The Medtronic Export XT Catheter may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site.

AI/ML Overview

I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, specific studies, sample sizes, expert involvement, adjudication methods, or ground truth details. The document is an FDA 510(k) clearance letter for the Medtronic Export XT Catheter, focusing on its substantial equivalence to a predicate device and outlining regulatory information. It does not contain details about specific performance studies or statistical data.

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).