Hansen Medical, Inc.
Mountain View, CA, US
Hansen Medical, Inc. appears in FDA device records in Mountain View, CA. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Hansen Medical, Inc. between 2006 and 2016. The busiest year on record is 2015, with 3. The most recent is 2016, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | DRA | Substantially Equivalent | |
| K153304 | Hansen Medical Magellan Robotic Catheter eKit | DRA | Substantially Equivalent | |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | DRA | Substantially Equivalent | |
| K151730 | Magellan Robotic System | DXX | Substantially Equivalent | |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr | DXX | Substantially Equivalent | |
| K141614 | MAGELLAN ROBOTIC SYSTEM | DXX | Substantially Equivalent | |
| K133552 | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT | DRA | Substantially Equivalent | |
| K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | DXX | Substantially Equivalent | |
| K122275 | ARTISAN EXTEND CONTROL CATHETER | DRA | Substantially Equivalent | |
| K111004 | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER | DXX | Substantially Equivalent | |
| K102168 | SENSEI X ROBOTIC CATHETER SYSTEM | DXX | Substantially Equivalent | |
| K091808 | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 | DXX | Unknown | |
| K090365 | HANSEN MEDICAL ARTISAN S CONTROL CATHETER | DXX | Unknown | |
| K082075 | HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER | DRE | Substantially Equivalent | |
| K073225 | SENSEI CATHETER CONTROL SYSTEM | DXX | Unknown | |
| K052480 | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH | DXX | Unknown | |
| K061070 | HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR | DRC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy. | Class II | Terminated | |
| Z-1449-2015 | Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites. | Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of catheter may not stop when equipment button is released. | Class II | Terminated | |
| 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. | The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall causing, uncontrolled catheter movement. cardiac tampenade, delayed procedure, or crush injury to the patient and/or user. | Class II | Terminated | |
| Z-1251-2010 | Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufactured by Hansen Medical, Inc, Mountain View, CA | Certain Artisan Extend Catheters may develop a leak in the flush assembly of the catheter which has the potential to cause flush fluid leakage and subsequent decrease in distal flush; inability to aspirate air from flush lines, and/or introduction of air into the catheter. | Terminated | ||
| Z-2106-2008 | Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to facilitate manipulation, positioning and control for collecting electrophysiological data within the heart atria. | The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of hemostasis, flush fluid leakage, and/or introduction of air into the catheter with a risk of subsequent embolism. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain