Hansen Medical, Inc.
Hansen Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2016, with 3 FDA device recalls on record.
Top product codes for Hansen Medical, Inc.
FDA recalls by Hansen Medical, Inc.
- Z-1564-2016 — Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
- Z-1449-2015 — Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
- Z-0896-2015 — Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hansen Medical, Inc.
- K160919 — Hansen Medical Magellan Robotic Catheter 9Fr
- K153304 — Hansen Medical Magellan Robotic Catheter eKit
- K151463 — Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
- K151730 — Magellan Robotic System
- K143227 — Magellan Robotic System, Magellan Robotic Catheter 10Fr
- K132369 — MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
- K111004 — HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
- K102168 — SENSEI X ROBOTIC CATHETER SYSTEM
- K091808 — SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
- K090365 — HANSEN MEDICAL ARTISAN S CONTROL CATHETER
- K082075 — HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
- K073225 — SENSEI CATHETER CONTROL SYSTEM
- K052480 — HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH
- K061070 — HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.