Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Steerable catheter control system

K-Number: K183027 · 2019-09-06

ApplicantStereotaxis, Inc.
Decision Date2019-09-06
Product CodePJB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Steerable catheter control system is a medical device manufactured by Stereotaxis, Inc.. It received FDA 510(k) clearance on 2019-09-06 under approval number K183027. The device is classified under product code PJB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steerable catheter control system?

Steerable catheter control system is a medical device that received FDA 510(k) clearance on 2019-09-06. It is manufactured by Stereotaxis, Inc.. The 510(k) number is K183027.

When was Steerable catheter control system approved by the FDA?

Steerable catheter control system received FDA 510(k) clearance on 2019-09-06, under approval number K183027.

What company makes Steerable catheter control system?

Steerable catheter control system is manufactured by Stereotaxis, Inc..

What is the FDA product code for Steerable catheter control system?

The FDA product code for Steerable catheter control system is PJB.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07614997 Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck NOT_YET_RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT05174312 Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) COMPLETED

Related PubMed Literature

PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

Other Devices by Stereotaxis, Inc.

K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) K250590MAGiC Sweep™ EP Mapping Catheter K253473Synchrony PMA P240014Cardiac ablation percutaneous catheter

View all 7 devices →

Related Devices (Code: PJB)

K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc. K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑