limflow.comLimFlow Vector
LimFlow, Inc.
LimFlow Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3023527320 | 3023527320 | LimFlow Inc. | 1 | N | 2026-01-01 | 6001 Oak Canyon Suite 100 Irvine CA US 92618 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850041730165 | LimFlow Crossing Stent Graft - LimFlow Crossing Stent Graft (3.5-5.5 mm x 60 mm). The LimFlow Crossing 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. | 18884787705 | info@limflow.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 338183 | 1375246659 | P220025 | LimFlow System | QWN | 2023-09-11 |
| 338183 | 1364420245 | K260188 | LimFlow Vector | MGZ | 2026-03-18 |
| 338183 | 1751635286 | K251376 | LimFlow ARC | PDU | 2025-05-31 |
| 338183 | 1266052062 | K242776 | LimFlow V-Ceiver | MMX | 2025-02-14 |
| 338183 | 1485288486 | K222083 | LimFlow V-Ceiver | MMX | 2022-08-09 |
| 338183 | 1960429727 | K221902 | LimFlow Vector | MGZ | 2022-12-21 |
| 338183 | 1315449841 | K221541 | LimFlow ARC | PDU | 2022-08-31 |
Product Codes Associated With Registrations#
PMN#
GUDID#
LimFlow Crossing Stent Graft - LimFlow Crossing Stent Graft (3.5-5.5 mm x 60 mm). The LimFlow Crossing 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.
2024-10-08
LimFlow Crossing Stent Graft - LimFlow Crossing Stent Graft (4.0-5.5 mm x 60 mm). The LimFlow Crossing 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.
2024-10-08
LimFlow Extension Stent Graft - LimFlow Extension Stent Graft (5.5 mm x 60 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.
2024-10-08
LimFlow Extension Stent Graft - LimFlow Extension Stent Graft (5.5 mm x 100 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.
2024-10-08
LimFlow Extension Stent Graft - LimFlow Extension Stent Graft (5.5 mm x 150 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.
2024-10-08
LimFlow Extension Stent Graft - 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.
2024-10-08
LimFlow ARC - The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature
2024-04-19
LimFlow Vector - The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
2024-04-12
LimFlow V-Ceiver - The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.
2024-03-09
LimFlow System - LimFlow Extension Stent Graft (5.5 mm x 200 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.
2023-10-02
LimFlow System - LimFlow Extension Stent Graft (5.5 mm x 150 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.
2023-10-02
LimFlow System - LimFlow Extension Stent Graft (5.5 mm x 100 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.
2023-10-02
LimFlow System - LimFlow Extension stent graft (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.
2023-10-02
LimFlow System - 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.
2023-10-02
LimFlow System - LimFlow Conical Stent Graft (4.0-5.5 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.
2023-10-02
LimFlow V-Ceiver - The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.
2023-06-26
LimFlow ARC - The LimFlow ARC is a 6 Fr compatible catheter designed to facilitate placement and positioning of guide wires within the peripheral vasculature
2023-06-26
LimFlow Vector - The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
2023-06-26