510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PJBClass II

Catheter Remote Control System

21 CFR 870.5700 / Cardiovascular
FDA source (opens on fda.gov)

PJB is the FDA product code for Catheter Remote Control System, a class II device type, regulated under 21 CFR 870.5700. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PJB
Device name
Catheter Remote Control System
FDA 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.
Regulation
21 CFR 870.5700
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code PJB

By decision year
4 clearances under product code PJB with a decision year between 2014 and 2020, 2019 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PJB by decision year
YearClearances
20141
20192
20201

Applicants with the most clearances

Product code PJB
Applicants holding the most 510(k) clearances under product code PJB
ApplicantClearances
Stereotaxis Inc3
Catheter Robotics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code