510(k) · Cleared
ClearedHansen Medical Magellan Robotic Catheter 9Fr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hansen Medical, Inc. · DRA Catheter, Steerable
Cleared on Sep 20, 2016 as substantially equivalent to K082385 (MicroVention, Inc., 2008) after a 169-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Sep 20, 2016
- Review
- 169 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010954 (2001). 6 ancestors in all, the oldest K010853 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 4 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 3 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 2 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 1 generation backK082385 Chaperon Guiding CatheterMicroVention, Inc. · 2008
- This deviceK160919 Hansen Medical Magellan Robotic Catheter 9FrHansen Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −4 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −3 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −2 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −1 | K082385 | Chaperon Guiding Catheter | MicroVention, Inc. | 2008 | — |
| 0 (this device) | K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | Hansen Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K082385 | Chaperon Guiding CatheterSummary page 4…The Hansen Medical Magellan Robotic Catheter 9Fr is substantially equivalent in intended use and method of operation to the MicroVention Chaperon 6Fr Guiding Catheter (K082385). Hansen Medical Traditional 510(k) Submission Page 5-1 of 6 MRC 9Fr Expanded Indication… | 2008 |
| † | K132369 | Magellan Robotic System, Magellan Robotic Catheter 9FR | 2013 |
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 15 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K082385.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Magellan™ Robotic Catheter 9Fr is intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.
The Magellan Robotic Catheter 9Fr Long Length (80 cm) is also indicated for use as a conduit for manual placement of therapeutic devices in the neuro vasculature.
The Magellan™ Robotic Catheter 9Fr is intended to be used with the Hansen Medical Magellan™ Robotic System and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160919: Hansen Medical Magellan Robotic Catheter 9Fr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160919
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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