AccessGUDID - DEVICE: XPRESS-WAY RX Catheter (6F LD-Version) (04540778139602)

GUDID

Device Identifier (DI) Information

Brand Name: XPRESS-WAY RX Catheter (6F LD-Version)
Version or Model: T2R6SA4L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KANEKA CORPORATION

Primary DI Number: 04540778139602
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690535406 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXE	Catheter, Embolectomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121301	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Compatible Guide Catheter; 6 French

Device Record Status

Public Device Record Key: 115eac36-fff2-44e9-90dd-71cb3ba4c5d2
Public Version Date: November 09, 2022
Public Version Number: 5
DI Record Publish Date: September 17, 2016