# Lumend, Inc.

- Location (FDA's records): Redwood City, CA
- FDA decisions: 11 (2001–2005): 11 510(k) clearances
- Product codes: DQY (8), PDU (3)
- Predicates its devices cite: 17 (10 its own); citations of its devices by later devices: 26 (10 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Intra Luminal Therapeutics, Inc.: 1 (https://510kreport.com/company/intra-luminal-therapeutics)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- Guidant Corp.: 1 (https://510kreport.com/company/guidant)
- Spectranetics Corp.: 1 (https://510kreport.com/company/spectranetics)
- Schneider Intl., Ltd.: 1 (https://510kreport.com/company/schneider-intl)
- Schneider (Europe) GmbH: 1 (https://510kreport.com/company/schneider-europe)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- Bridge Medical, Inc.: 5 (https://510kreport.com/company/bridge-medical)
- Bridgepoint Medical: 2 (https://510kreport.com/company/bridgepoint-medical)
- Avinger, Inc.: 1 (https://510kreport.com/company/avinger)
- Cordis Corp., A Johnson & Johnson Co.: 1 (https://510kreport.com/company/cordis-a-johnson-johnson)
- Trans Vascular Incorporated: 1 (https://510kreport.com/company/trans-vascular)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)
- Upstream Peripheral Technologies: 1 (https://510kreport.com/company/upstream-peripheral-technologies)
- AngioSafe, Inc.: 1 (https://510kreport.com/company/angiosafe)

## Its most-cited devices
- K001577: Outback Catheter (2001), cited by 5
- K023114: Lumend Frontrunner Cto Catheter (2003), cited by 3
- K011562: Lumend Percutaneous Catheter (2002), cited by 3
- K013284: Lumend Frontrunner Cto Coronary Catheter (2002), cited by 3
- K033535: Lumend Frontrunner Cto Catheter and Accessories (2004), cited by 3
- K031005: Lumend Frontrunner GW Cto Catheter (2003), cited by 2

## Recent decisions
- K043534: Modification to Outback Catheter (Jan 21, 2005)
- K040771: Modification to Outback Catheter (Apr 23, 2004)
- K033535: Lumend Frontrunner Cto Catheter and Accessories (Jan 7, 2004)
- K032298: Modification to Outback Catheter (Aug 26, 2003)
- K031005: Lumend Frontrunner GW Cto Catheter (Jun 18, 2003)
- K023114: Lumend Frontrunner Cto Catheter (Jan 23, 2003)
- K023223: Modification to Lumend Frontrunner Cto Catheter (Oct 24, 2002)
- K013284: Lumend Frontrunner Cto Coronary Catheter (Feb 11, 2002)

Source page: https://510kreport.com/company/lumend