510(k) · Cleared
ClearedArtisan Extend Control Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hansen Medical · DRA Catheter, Steerable
Cleared on Aug 29, 2012 as substantially equivalent to K073225 (Hansen Medical, Inc., 2008) after a 30-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Aug 29, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K900765 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK122275 Artisan Extend Control CatheterHansen Medical · 2012
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) | K122275 | Artisan Extend Control Catheter | Hansen Medical | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 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 DRA? 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 DRA device
- #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 6 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…heter is substantially equivalent in intended use and method of operation to the Hansen Medical Steerable Guide Catheter (SGC) and Sheath ('ArtisanO© Control Catheter")-(K073225). Device Description: The Hansen Medical Artisan Extend Control Catheter is designed to facilitate manipulation, positioning an… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K073225.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRA
89in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRA
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRA
4,018in 2025
MAUDE reports naming product code DRA, 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 | 1 | — | 0 | 6 |
| 2008 | 1 | — | 1 | 23 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 29 | 0 | 2 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 4 | 70 | 0 | 89 |
| 2013 | 0 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 212 |
| 2015 | 1 | — | 0 | 350 |
| 2016 | 4 | 123 | 0 | 481 |
| 2017 | 2 | — | 0 | 625 |
| 2018 | 1 | — | 0 | 633 |
| 2019 | 2 | — | 0 | 700 |
| 2020 | 1 | — | 0 | 703 |
| 2021 | 1 | — | 0 | 741 |
| 2022 | 2 | — | 0 | 652 |
| 2023 | 3 | 89 | 0 | 788 |
| 2024 | 0 | — | 0 | 1,962 |
| 2025 | 1 | — | 0 | 4,018 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The Hansen Medical Artisan Extend 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-DxTM
Steerable Diagnostic catheters made by Boston Scientific Corporation and
the Livewire TM Electrophysiology catheters made by St. Jude Medical.
The Artisan Extend Control Catheter is intended to be used with the Hansen
Medical Sensei® X Robotic Catheter System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122275 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122275: Artisan Extend 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/K122275
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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