LimFlow System

Basic Information

• Brand Name: LimFlow System
• Primary DI: 00850041730097
• Version / Model: SGH-35060-US-21
• Company Name: Limflow Inc.
• Labeler DUNS: 096651686
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-02
• Public Version: 1
• Public Version Date: 2023-10-10
• Public Version Status: New
• Public Device Record Key: 9a958731-31d3-4939-8ee0-feb509c08bb9

Device Description

LimFlow Conical Stent Graft (3.5-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• 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
QWN	Stent Graft, Infrapopliteal, Venous Arterialization	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
62528	Arteriovenous endovascular stent-graft	A 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850041730097	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P220025	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry, and dark place