510(k) · Decided
Recalled · 2009Hansen Medical Artisan S Control Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hansen Medical, Inc. · DXX System, Catheter Control, Steerable
Cleared on May 7, 2009 as substantially equivalent to K073225 (Hansen Medical, Inc., 2008) after an 83-day review. Its family tree reaches back 5 generations to 1990. 22 later devices descend from it. It has been recalled once.
- Decided
- May 7, 2009
- Review
- 83 days
- Class
- Class II
- Product code
- DXX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K900765 (1990). 7 ancestors in all. 22 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 4 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 3 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 2 generations backK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- 1 generation backK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- This deviceK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009
- Descendant · cites it directly · 19 of its ownK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 12 of its ownK102168 Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 10 of its ownK111004 Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 9 of its ownK132369 Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 8 of its ownK120834 Corpath 200 SystemCorindus, Inc. · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K091808Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · cites it directly19descendants
- K102168Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · 2 generations on12descendants
- K111004Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012 · 3 generations on10descendants
- K132369Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 2013 · 4 generations on9descendants
- K120834Corpath 200 SystemCorindus, Inc. · 2012 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −4 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −3 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −2 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| −1 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| 0 (this device) | K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | 2009 | — |
| +1 | K091808 | Sensei Robotic Catheter System, Model 02057 | Hansen Medical, Inc. | 2009 | 1 |
| +2 | K102168 | Sensei X Robotic Catheter System | Hansen Medical, Inc. | 2010 | 1 |
| +3 | K111004 | Hansen Medical Vascular Catheter Control System and Catheter | Hansen Medical, Inc. | 2012 | 2 |
| +4 | K132369 | Magellan Robotic System, Magellan Robotic Catheter 9FR | Hansen Medical, Inc. | 2013 | 2 |
| +2 | K120834 | Corpath 200 System | Corindus, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXX device
- #1 K251792 Stereotaxis GenesisX RMN with Navigant ™…score 13.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073225 | Sensei Catheter Control SystemSummary page 1…atheter is substantially equivalent in intended use and method of operation to the Hansen Medical Steerable Guide Catheter (SGC) and Sheath ("Artisan Control Catheter") (K073225). Device Description: The Hansen Medical Artisan S Control Catheter is designed to facilitate manipulation, positioning and con… | 2008 |
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 19, 2009 | Not classified | Z-1251-2010 | Other | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K091808 (Hansen Medical, Inc., 2009) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K073225.
How does its category compare?
All DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DXX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXX
76in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXX
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXX
1in 2024
MAUDE reports naming product code DXX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 4 | 155 | 0 | 2 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 4 | 104 | 1 | 14 |
| 2015 | 4 | 156 | 0 | 2 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 3 | 76 | 0 | 9 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Hansen Medical Artisan S Control Catheter is intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx TM Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire TM Electrophysiology catheters made by St. Jude Medical.
The Control Catheter is intended to be used with the Hansen Medical Sensei® Robotic Catheter System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090365 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090365: Hansen Medical Artisan S Control Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090365
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026