LimFlow System

GUDID 00850041730097

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.

Limflow Inc.

Arteriovenous endovascular stent-graft
Primary Device ID00850041730097
NIH Device Record Key9a958731-31d3-4939-8ee0-feb509c08bb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLimFlow System
Version Model NumberSGH-35060-US-21
Company DUNS096651686
Company NameLimflow Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, and dark place

Device Identifiers

Device Issuing AgencyDevice ID
GS100850041730097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QWNStent Graft, Infrapopliteal, Venous Arterialization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-10
Device Publish Date2023-10-02

On-Brand Devices [LimFlow System]

00850041730110LimFlow Conical Stent Graft (4.0-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow Sy
00850041730097LimFlow Conical Stent Graft (3.5-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow Sy
00850041730073LimFlow Extension stent graft (5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow Syst
00850041730059LimFlow Extension Stent Graft (5.5 mm x 100 mm) with the Handle Delivery System. The LimFlow Sys
00850041730042LimFlow Extension Stent Graft (5.5 mm x 150 mm) with the Handle Delivery System. The LimFlow Sys
00850041730035LimFlow Extension Stent Graft (5.5 mm x 200 mm) with the Handle Delivery System. The LimFlow Sys

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