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Limflow Inc. manufactures endovascular stent-grafts for arteriovenous applications, including the LimFlow System and LimFlow Extension Stent Graft, designed for vascular repair. Their portfolio also includes intravascular extraction catheters (LimFlow Vector) and snares for clot or device retrieval, as well as percutaneous valvulotomes (LimFlow V-Ceiver) for valve intervention. Single-use vascular guide-catheters and crossing stent-grafts (LimFlow ARC, LimFlow Crossing Stent Graft) are used to facilitate complex vascular procedures.
The company’s devices are regulated under FDA Class II and Class III classifications, with some products authorised via the Premarket Approval (PMA) pathway and others through the Unique Device Identifier (UDI) listing. These products are registered in the FDA’s regulatory databases, ensuring compliance with US medical device regulations. Limflow Inc. is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- 6001 Oak Canyon, Irvine, CA, 92618
- Website
- limflow.com
- —
- —
- [email protected]
- Phone
- 18884787705
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3023527320
- DUNS Number
- 096651686
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LimFlow System | SGH-40060-US-21 | FDA UDI | Class III | Active |
| LimFlow Vector | VT-US-23 | FDA UDI | Class II | Active |
| LimFlow System | SGH-55100-US-21 | FDA UDI | Class III | Active |
| LimFlow System | SGH-35060-US-21 | FDA UDI | Class III | Active |
| LimFlow System | SGH-55150-US-21 | FDA UDI | Class III | Active |
| LimFlow ARC | AC-US-21 | FDA UDI | Class II | Active |
| LimFlow Extension Stent Graft | RGS-55060-US-24 | FDA UDI | Class III | Active |
| LimFlow System | SGH-55200-US-21 | FDA UDI | Class III | Active |
| LimFlow V-Ceiver | VC-US-21 | FDA UDI | Class II | Active |
| LimFlow ARC | AC-US-23 | FDA UDI | Class II | Active |
| LimFlow Crossing Stent Graft | RGS-35060-US-24 | FDA UDI | Class III | Active |
| LimFlow System | SGH-55060-US-21 | FDA UDI | Class III | Active |
| LimFlow Vector | VT-US-21 | FDA UDI | Class II | Active |
| LimFlow Extension Stent Graft | RGS-55200-US-24 | FDA UDI | Class III | Active |
| LimFlow V-Ceiver | VC-US-23 | FDA UDI | Class II | Active |
| LimFlow Extension Stent Graft | RGS-55150-US-24 | FDA UDI | Class III | Active |
| LimFlow Crossing Stent Graft | RGS-40060-US-24 | FDA UDI | Class III | Active |
| LimFlow Extension Stent Graft | RGS-55100-US-24 | FDA UDI | Class III | Active |
| LimFlow System | P220025 | FDA PMA | Class III | Active |
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