FDA.reportPublic FDA data

FLOWRUNNER 14F Aspiration System, 80cm

Primary DI
00860011713104
Brand
FLOWRUNNER 14F Aspiration System, 80cm
Company
Expanse Medical, Inc.
Model
FLWRNR08014
Catalog number
FLWRNR08014
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.
Published
2026-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush
QEZAspiration Thrombectomy Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
QEZAspiration Thrombectomy CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234073000
K251488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234073000ICE Aspiration SystemExpanse Medical, Inc.2024-04-19QEW
K251488000FLOWRUNNER Aspiration SystemExpanse Medical, Inc.2025-07-14QEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011713104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011713104008600117131048600117131040860011713104

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterization kitA 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.

Regulatory Flags#

DUNS number
118497230
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011713135FLOWRUNNER 7F Aspiration System, 130cmFLWRNR13007FLWRNR130072026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmFLWRNR13007SPFLWRNR13007SP2026-05-28
00860011713111FLOWRUNNER 12F Aspiration System, 120cmFLWRNR12012FLWRNR120122026-01-12
00860011713128FLOWRUNNER 12F Aspiration System, 80cmFLWRNR08012FLWRNR080122026-01-12
00860011713142FLOWRUNNER 14F Aspiration System, 120cmFLWRNR12014FLWRNR120142026-01-12
00860011713166FLOWRUNNER 12F Aspiration System, 100cmFLWRNR10012FLWRNR100122026-01-12
00860011713180FLOWRUNNER 14F Aspiration System, 100cmFLWRNR10014FLWRNR100142026-01-12

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B090A70600Control 7F Mechanical Thrombectomy SystemZien Medical Technologies, LLCQEZ2022-06-29
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
07640132622690M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01