FDA product code PJB: Catheter Remote Control System
PJB is the FDA product code for catheter remote control system. It is a Class II device, regulated under 21 CFR 870.5700 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under PJB. The average 510(k) review took 151 days (median 113). 1 De Novo request was granted under it. FDA has posted 1 recall for PJB devices.
Definition
A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.
Classification
| Field | Value |
|---|---|
| Device name | Catheter Remote Control System |
| Device class | Class II |
| Regulation | 21 CFR 870.5700 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for PJB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 170 |
| 2020 | 1 | 113 |
Compare with all 510(k) review times · Search every PJB clearance
Top PJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stereotaxis, Inc. | 3 | 2020-03-05 |
Most recent PJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193147 | Stereotaxis, Inc. | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | 2020-03-05 | 113 |
| K192775 | Stereotaxis, Inc. | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | 2019-10-30 | 30 |
| K183027 | Stereotaxis, Inc. | Steerable catheter control system | 2019-09-06 | 309 |
Recalls for PJB devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-09-21.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code PJB?
PJB is the FDA product code for catheter remote control system. It is a Class II device, regulated under 21 CFR 870.5700 and reviewed by the Cardiovascular panel.
What device class is PJB?
Class II, regulation 21 CFR 870.5700. Typical premarket route: 510(k).
How long does a 510(k) take for product code PJB?
Across 3 cleared submissions the average was 151 days from receipt to decision (median 113).
Which companies have the most PJB clearances?
Stereotaxis, Inc. (3).
Have PJB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-09-21.
Next steps
- Run an FDA pathway report with predicate devices for product code PJB
- Run a recall and safety report across every PJB manufacturer
- Watch product code PJB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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