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K Number
K101839
Device Name
KANEKA PHARMA AMERICA XPRESS-WAY RX
Manufacturer
KANEKA PHARMA AMERICA LLC
Date Cleared
2010-10-22

(113 days)

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

The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system. The Xpress-Way RX is not intended for use in the cerebral vasculature.

Device Description

Not Found

AI/ML Overview

The provided documents are FDA 510(k) clearance letters for the Xpress-Way RX embolectomy catheter. These letters confirm the device's substantial equivalence to predicate devices but do not contain information about acceptance criteria, study designs, performance data, or ground truth establishment.

Therefore, I cannot provide the requested information based solely on the given text. To describe the acceptance criteria and the study that proves the device meets them, I would need to access the actual 510(k) submission (K101839) or related performance studies, which are not included in these documents.

§ 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).