FDA.reportPublic FDA data

FLOWRUNNER SP 7F Aspiration System, 130cm

Primary DI
00860011713159
Brand
FLOWRUNNER SP 7F Aspiration System, 130cm
Company
Expanse Medical, Inc.
Model
FLWRNR13007SP
Catalog number
FLWRNR13007SP
Device description
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 with the ability to infuse fluids. 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
2026-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K251488000
K254208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251488000FLOWRUNNER Aspiration SystemExpanse Medical, Inc.2025-07-14QEZ
K254208000FLOWRUNNER Aspiration SystemExpanse Medical, Inc.2026-03-20QEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011713159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011713159008600117131598600117131590860011713159

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011713135FLOWRUNNER 7F Aspiration System, 130cmFLWRNR13007FLWRNR130072026-05-28
00860011713104FLOWRUNNER 14F Aspiration System, 80cmFLWRNR08014FLWRNR080142026-01-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.QEZ2026-05-28
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023825Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023832Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023849Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023856Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023863Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023870Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023887Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023894Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023900Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023924Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023931Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023948Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
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07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
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10351688505620MedexICU MEDICAL, INC.KRA2016-12-29
10351688506856MedexICU MEDICAL, INC.KRA2016-10-12
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