Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Johnson & JohnsonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record. See the Johnson & Johnson group view.
As of Nov 15, 2026, FDA's public records list Hansen Medical with 17 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Sep 20, 2016: Hansen Medical Magellan Robotic Catheter 9Fr.
| Sep 20, 2016 | Hansen Medical Magellan Robotic Catheter 9FrK160919 · DRA | 510(k) clearances |
| Mar 25, 2016 | Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic cClass II · Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not me | Device recalls |
| Feb 1, 2016 | Hansen Medical Magellan Robotic Catheter eKitK153304 · DRA | 510(k) clearances |
| Aug 18, 2015 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsK151463 · DRA | 510(k) clearances |
| Jul 23, 2015 | Magellan Robotic SystemK151730 · DXX | 510(k) clearances |
| Jul 1, 2015 | Magellan Robotic System, Magellan Robotic Catheter 10FrK143227 · DXX | 510(k) clearances |
| Mar 18, 2015 | Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.Class II · Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139 | Device recalls |
| Dec 4, 2014 | Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter lClass II · The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table wi | Device recalls |
| Aug 7, 2014 | MAGELLAN ROBOTIC SYSTEMK141614 · DXX | 510(k) clearances |
| Feb 7, 2014 | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KITK133552 · DRA | 510(k) clearances |
| Sep 27, 2013 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FRK132369 · DXX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
