# Hansen Medical, Inc.

- Location (FDA's records): Mountain View, CA
- FDA decisions: 17 (2006–2016): 17 510(k) clearances
- Names in FDA's records: Hansen Medical, Inc. (14); Hansen Medical (3)
- Product codes: DXX (10), DRA (5), DRC (1), DRE (1)
- Predicates its devices cite: 18 (13 its own); citations of its devices by later devices: 20 (13 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Thomas Medical Products, Inc.: 2 (https://510kreport.com/company/thomas-medical-products)
- Stereotaxis, Inc.: 1 (https://510kreport.com/company/stereotaxis)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)
- MicroVention, Inc.: 1 (https://510kreport.com/company/microvention)

## Firms that cite its devices most
- Corindus, Inc.: 3 (https://510kreport.com/company/corindus)
- Hanson Medical, Inc.: 1 (https://510kreport.com/company/hanson-medical)
- Microbot Medical, Ltd.: 1 (https://510kreport.com/company/microbot-medical)
- Stereotaxis, Inc.: 1 (https://510kreport.com/company/stereotaxis)
- Catheter Robotics, Inc.: 1 (https://510kreport.com/company/catheter-robotics)

## Its most-cited devices
- K132369: Magellan Robotic System, Magellan Robotic Catheter 9FR (2013), cited by 2
- K052480: Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable Guide Catheter (SGC) and Sheath (2007), cited by 2
- K111004: Hansen Medical Vascular Catheter Control System and Catheter (2012), cited by 2
- K102168: Sensei X Robotic Catheter System (2010), cited by 2
- K141614: Magellan Robotic System (2014), cited by 2
- K090365: Hansen Medical Artisan S Control Catheter (2009), cited by 2

## Recent decisions
- K160919: Hansen Medical Magellan Robotic Catheter 9Fr (Sep 20, 2016)
- K153304: Hansen Medical Magellan Robotic Catheter eKit (Feb 1, 2016)
- K151463: Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components (Aug 18, 2015)
- K151730: Magellan Robotic System (Jul 23, 2015)
- K143227: Magellan Robotic System, Magellan Robotic Catheter 10Fr (Jul 1, 2015)
- K141614: Magellan Robotic System (Aug 7, 2014)
- K133552: Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR Accessory Kit (Feb 7, 2014)
- K132369: Magellan Robotic System, Magellan Robotic Catheter 9FR (Sep 27, 2013)

Source page: https://510kreport.com/company/hansen-medical