LimFlow Extension Stent Graft

Primary DI
00850041730219
Brand
LimFlow Extension Stent Graft
Company
Inari Medical, Inc.
Model
RGS-55200-US-24
Device description
LimFlow Extension Stent Graft (5.5 mm x 200 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Published
2024-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QWNStent Graft, Infrapopliteal, Venous Arterialization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWNStent Graft, Infrapopliteal, Venous ArterializationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220025002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220025002LimFlow SystemLimFlow, Inc.2023-09-11QWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041730219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041730219008500417302198500417302190850041730219

GMDN Terms#

Term, Definition table
TermDefinition
Arteriovenous endovascular stent-graftA non-bioabsorbable, implantable tubular device intended to treat critical lower-limb ischemia by creating a communication (shunt) between an artery and a vein to produce venous arterialization in the below-knee vasculature for restoration of blood flow. It is implanted in a minimally-invasively procedure using vascular ultrasound catheters, one in an artery and one in a vein, to create a cross-bridge as a guide for positioning the stent-graft at the site of implantation, where it self-expands. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and covered by a polymer [e.g., polytetrafluoroethylene (PTFE)]. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18884787705info@limflow.com

Regulatory Flags#

DUNS number
076827459
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810123710249Artix AX31-1012026-01-06
00810123710256Artix AX31-1022026-01-06
00810123710270Intri26 Introducer Sheath52-1022026-01-06
00810123710126InThrill Thrombectomy Catheter43-10243-1022025-05-30
00810123710294InThrill Sheath53-10153-1012025-05-30
00810123710157FlowTriever2 Catheter11-10211-1022025-05-28
00810123710393ClotTriever BOLD Catheter42-1022025-04-09
00850291007352InThrill Thrombectomy Catheter43-10243-1022024-12-20
00850291007697Large Bore 60 cc Syringe99-10299-1022024-12-20
00810123710577Artix Thin-Walled Sheath30-104 / AS-012062024-11-11
00810123710584Artix MT32-102 / AS-012482024-11-11
00810123710591Artix MT32-103 / AS-0124432-1032024-11-11
00810123710560Artix Thin-Walled Sheath30-103 / AS-012162024-11-07
0081012371047816 Fr Evacuation System131-101 / AS-012262024-10-10
0081012371048524 Fr Evacuation System131-102 / AS-012292024-10-10
00850041730165LimFlow Crossing Stent GraftRGS-35060-US-242024-10-08
00850041730172LimFlow Crossing Stent GraftRGS-40060-US-242024-10-08
00850041730189LimFlow Extension Stent GraftRGS-55060-US-242024-10-08
00850041730196LimFlow Extension Stent GraftRGS-55100-US-242024-10-08
00850041730202LimFlow Extension Stent GraftRGS-55150-US-242024-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850041730165LimFlow Crossing Stent GraftInari Medical, Inc.QWN2024-10-08
00850041730172LimFlow Crossing Stent GraftInari Medical, Inc.QWN2024-10-08
00850041730189LimFlow Extension Stent GraftInari Medical, Inc.QWN2024-10-08
00850041730196LimFlow Extension Stent GraftInari Medical, Inc.QWN2024-10-08
00850041730202LimFlow Extension Stent GraftInari Medical, Inc.QWN2024-10-08
00850041730035LimFlow SystemInari Medical, Inc.QWN2023-10-02
00850041730042LimFlow SystemInari Medical, Inc.QWN2023-10-02
00850041730059LimFlow SystemInari Medical, Inc.QWN2023-10-02
00850041730073LimFlow SystemInari Medical, Inc.QWN2023-10-02
00850041730097LimFlow SystemInari Medical, Inc.QWN2023-10-02
00850041730110LimFlow SystemInari Medical, Inc.QWN2023-10-02