De Novo · Granted
GrantedAmigo Remote Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catheter Robotics, Inc. · PJB Catheter Remote Control System
Granted on Dec 18, 2014 as a new device type through De Novo after a 303-day review. 3 later devices descend from it.
- Decided
- Dec 18, 2014
- Review
- 303 days
- Class
- Class II
- Product code
- PJB
- Recalls
- None
3 later devices descend from it, 1 citing it directly.
- This deviceDEN140009 Amigo Remote Catheter SystemCatheter Robotics, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK183027 Steerable catheter control systemStereotaxis, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK192775 Niobe® Magnetic Navigation System (MNS) with Navigant Workstation…Stereotaxis, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK193147 Stereotaxis Genesis RMN with Navigant Workstation (NWS) and…Stereotaxis, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K183027Steerable catheter control systemStereotaxis, Inc. · 2019 · cites it directly2descendants
- K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc. · 2019 · 2 generations on1descendant
- K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN140009 | Amigo Remote Catheter System | Catheter Robotics, Inc. | 2014 | — |
| +1 | K183027 | Steerable catheter control system | Stereotaxis, Inc. | 2019 | — |
| +2 | K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and… | Stereotaxis, Inc. | 2019 | 1 |
| +3 | K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | Stereotaxis, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
Sources: FDA De Novo 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 PJB? 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 PJB device
- #1 K193147 Stereotaxis Genesis RMN with Navigant…score 0.8 · 7 generations · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183027 | Steerable catheter control system | 2019 | 2 |
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?
- Of its descendants, K183027 (Stereotaxis, Inc., 2019) has gone furthest, with 2 descendants of its own.
How does its category compare?
All PJB devicesPJB Catheter Remote Control System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PJB
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PJB
Too few PJB 510(k)s in any year since 2007 to give a median.
Recalls per year · PJB
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PJB
1in 2025
MAUDE reports naming product code PJB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
to facilitate manipulation, positioning and control of compatible percutaneous electrophysiological ablation catheters that deliver RF energy for treatment of cardiac arrhythmias in the right atrium. Use of Amigo RCS should also be in accordance with the indications for use of compatible ablation catheters. The Amigo RCS should only be used with the Boston Scientific catheters (with the BlazerTM handle) and/or the Biosense Webster catheters (with the EZ Steer® handle) in the right atrium
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN140009 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN140009: Amigo Remote Catheter System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN140009
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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