FDA UDI
In Commercial Distribution
🇺🇸 United States
FLOWRUNNER 14F Aspiration System, 100cm
DI: 00860011713180
·
Model: FLWRNR10014
·
Expanse Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FLOWRUNNER 14F Aspiration System, 100cm
- Primary DI
- 00860011713180
- Version / Model
- FLWRNR10014
- Catalog Number
- FLWRNR10014
- Company Name
- Expanse Medical, Inc.
- Labeler DUNS
- 118497230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-12
- Public Version
- 1
- Public Version Date
- 2026-01-20
- Public Version Status
- New
- Public Device Record Key
- be8cc02f-c1b5-47b1-b230-c37ad6a50a1c
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | Cardiovascular | 870.5150 | 2 |
| KRA | Catheter, Continuous Flush | Cardiovascular | 870.1210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66971 | Thrombectomy suction catheterization kit | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860011713180 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251488 | 000 |