# Lumen Biomedical, Inc.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 5 (2006–2011): 5 510(k) clearances
- Product codes: NTE (2), QEZ (2), QEW (1)
- Predicates its devices cite: 21 (4 its own); citations of its devices by later devices: 6 (4 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vascular Solutions, Inc.: 4 (https://510kreport.com/company/vascular-solutions)
- Kerberos Proximal Solutions, Inc.: 2 (https://510kreport.com/company/kerberos-proximal-solutions)
- Medtronic Vascular: 2 (https://510kreport.com/company/medtronic-vascular)
- Boston Scientific Epi: 1 (https://510kreport.com/company/boston-scientific-epi)
- Ev3, Inc.: 1 (https://510kreport.com/company/ev3)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Atrium Medical Corp.: 1 (https://510kreport.com/company/atrium-medical)

## Firms that cite its devices most
- Control Medical Technology: 2 (https://510kreport.com/company/control-medical-technology)

## Its most-cited devices
- K071529: Xtract Catheter System (2007), cited by 3
- K082348: Fibernet Embolic Protection System (2008), cited by 1
- K080901: Lbi Embolectomy System (2008), cited by 1
- K053372: Lbi Catheter System (2006), cited by 1

## Recent decisions
- K111987: Fibernet Embolic Protection Device (Aug 17, 2011)
- K082348: Fibernet Embolic Protection System (Nov 18, 2008)
- K080901: Lbi Embolectomy System (Oct 2, 2008)
- K071529: Xtract Catheter System (Aug 10, 2007)
- K053372: Lbi Catheter System (Jun 30, 2006)

Source page: https://510kreport.com/company/lumen-biomedical