Device
The Expanse FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components:
Manufacturer
Expanse Medical, Inc.
Expanse Medical, Inc.
Model: FLWRNR10014
Catalog: FLWRNR10014
DI: 00860011713180
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-01-12
Current Version: 2026-05-07
Description
The Expanse FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components:
- FLOWRUNNER Aspiration Catheter
- FLOWRUNNER Aspiration Sheath
- Vacuum Fitting
- High Flow Stopcock
- Y-Connector with Hemostatic Valve
- Hand Actuator Clip.
The FLOWRUNNER Aspiration System is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. It is a single use, over-the-wire, catheter-based system. The FLOWRUNNER Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and one hand actuator clip.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
be8cc02f-c1b5-47b1-b230-c37ad6a50a1c
Distribution Status:
In Commercial Distribution
DUNS Number:
118497230
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860011713180
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66971
Name: Thrombectomy suction catheterization kit
Definition:
A collection of devices intended to be used during a percutaneous transluminal thrombectomy suction procedure (in conjunction with a syringe or dedicated suction pump system) and which includes a thrombectomy suction catheter and additional devices intended to support catheter introduction and function (e.g., dilator, clot buster, haemostasis valve, aspiration tubing). This is a single-use device.
FDA Product Codes
QEZ
Aspiration Thrombectomy Catheter
KRA
Catheter, Continuous Flush