XPRESS-WAY RX

Basic Information

• Brand Name: XPRESS-WAY RX
• Primary DI: 04540778133983
• Version / Model: T2R7SA4A
• Company Name: KANEKA CORPORATION
• Labeler DUNS: 690535406
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 5
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 9ed39d7f-7bef-4b16-b96f-020f9de19084

Device Description

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 Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXE	Catheter, Embolectomy	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04540778133983	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K101839	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Compatible Guide Catheter; 7 French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.