Model: LMT-CTRX
DI: 00763000998011
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-09
Current Version: 2026-05-18
Description
CATHETER LMT-CTRX LIBERANT RX
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f616e611-609b-42e1-a73e-6f0e6dd3d82b
Distribution Status:
In Commercial Distribution
DUNS Number:
006261481
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00763000998011
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58173
Name: Thrombectomy suction catheter
Definition:
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.
FDA Product Codes
KRA
Catheter, continuous flush
QEZ
Aspiration thrombectomy catheter
Premarket Submissions
Submission Number:
K253589
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
0.36
Item #1 - Size Type:
Guidewire Diameter
Item #2 - Size - @attributes - Unit:
Centimeter
Item #2 - Size - @attributes - Value:
140.0
Item #2 - Size Type:
Length
Item #3 - Size Text:
Shaft-proximal outer diameter: 1.37 MM
Item #3 - Size Type:
Device Size Text, specify
Item #4 - Size - @attributes - Unit:
French
Item #4 - Size - @attributes - Value:
6.0
Item #4 - Size Type:
Guidewire Compatibility
Item #5 - Size - @attributes - Unit:
Millimeter
Item #5 - Size - @attributes - Value:
1.78
Item #5 - Size Type:
Catheter Inner Diameter
Item #6 - Size Text:
Dual lumen outer diameter: 1.73 MM
Item #6 - Size Type:
Device Size Text, specify
Item #7 - Size Text:
Introducer sheath: 5 FR
Item #7 - Size Type:
Device Size Text, specify
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Keep dry