Lumen Biomedical, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Lumen Biomedical, Inc. makes
Lumen Biomedical, Inc. manufactures endovascular devices for the removal of vascular blockages and protection during interventional procedures. The LBI Embolectomy System and Xtract Catheter System are designed to mechanically retrieve thrombi and emboli from arteries. The FiberNet Embolic Protection Device and FiberNet Embolic Protection System are intended to capture debris during peripheral interventions, reducing distal embolization risk. The LBI Catheter System supports catheter-based interventions in peripheral vascular applications.
These devices are classified as Class II under the FDA’s regulatory framework and are listed via the 510(k) clearance pathway. The company’s portfolio is authorized for use in the United States. No additional registries or international listings are referenced in the provided data.
Catalogue
Lbi Embolectomy System Ref K080901
Regimes: 510(k) Registry: 510(k)Fibernet Embolic Protection Device Ref K111987
Regimes: 510(k) Registry: 510(k)Xtract Catheter System Ref K071529
Regimes: 510(k) Registry: 510(k)Fibernet Embolic Protection System Ref K082348
Regimes: 510(k) Registry: 510(k)Lbi Catheter System Ref K053372
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lumen Biomedical, Inc. have in the registry?
The registry currently lists 5 devices for Lumen Biomedical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lumen Biomedical, Inc.'s devices?
Among its 5 most recently registered devices, Lumen Biomedical, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Lumen Biomedical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Lumen Biomedical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lumen Biomedical, Inc. in the registry?
The most recently registered devices listed for Lumen Biomedical, Inc. include LBI EMBOLECTOMY SYSTEM, FIBERNET EMBOLIC PROTECTION DEVICE, XTRACT CATHETER SYSTEM and FIBERNET EMBOLIC PROTECTION SYSTEM.