FDA applicant

Hansen Medical, Inc.

Mountain View, CA17 decisions2006–20165 recalls

FDA records 17 decisions for Hansen Medical, Inc. (Mountain View, CA) from 2006 to 2016: 17 510(k) clearances. Most are in product codes DXX (System, Catheter Control, Steerable) and DRA (Catheter, Steerable). Its devices cite 18 predicates, 13 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Hansen Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Hansen Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2007high 3 (2015) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hansen Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hansen Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

DXXSystem, Catheter Control, Steerable10decisions
DRACatheter, Steerable5decisions
DRCTrocar1decision
DREDilator, Vessel, For Percutaneous Catheterization1decision

Whose devices does it build on?

Its devices cite 18 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 13 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

K132369Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 20132cite it
K052480Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable Guide Catheter (SGC)…Hansen Medical, Inc. · 20072cite it
K111004Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 20122cite it
K102168Sensei X Robotic Catheter SystemHansen Medical, Inc. · 20102cite it
K141614Magellan Robotic SystemHansen Medical · 20142cite it
K090365Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 20092cite it

What has FDA decided for it lately?

K160919Hansen Medical Magellan Robotic Catheter 9FrHansen Medical, Inc. · 2016
K153304Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc. · 2016
K151463Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsHansen Medical, Inc. · 2015
K151730Magellan Robotic SystemHansen Medical, Inc. · 20151 recall
K143227Magellan Robotic System, Magellan Robotic Catheter 10FrHansen Medical, Inc. · 2015
K141614Magellan Robotic SystemHansen Medical · 20142 recalls
K133552Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR Accessory KitHansen Medical · 2014
K132369Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 20132 recalls

All 14 as Hansen Medical, Inc. →All 3 as Hansen Medical →

What has been recalled?

5 recalls linked to its devices; the latest:

K111004Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology…Mar 25, 2016Class II
K111004Magellan Robotic System; Model No (s). 11132 and 11139. A steerable catheter control…Mar 18, 2015Class II
K052480Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint…Dec 4, 2014Class II
K090365Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei…Oct 19, 2009
K052480Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc.…May 21, 2008

Other applicant names beginning “Hansen”

FDA records each applicant name separately; these may or may not be the same firm.

Hansen Ophthalmic Development Lab 1