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)

Neonav ECG Tip Location System

K-Number: K241910 · 2025-01-19

ApplicantNavi Medical Technologies
Decision Date2025-01-19
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Neonav ECG Tip Location System is a medical device manufactured by Navi Medical Technologies. It received FDA 510(k) clearance on 2025-01-19 under approval number K241910. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neonav ECG Tip Location System?

Neonav ECG Tip Location System is a medical device that received FDA 510(k) clearance on 2025-01-19. It is manufactured by Navi Medical Technologies. The 510(k) number is K241910.

When was Neonav ECG Tip Location System approved by the FDA?

Neonav ECG Tip Location System received FDA 510(k) clearance on 2025-01-19, under approval number K241910.

What company makes Neonav ECG Tip Location System?

Neonav ECG Tip Location System is manufactured by Navi Medical Technologies.

What is the FDA product code for Neonav ECG Tip Location System?

The FDA product code for Neonav ECG Tip Location System is LJS.

Related Clinical Trials

NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT03636230 Virtual E-health System for Pacemakers ACTIVE_NOT_RECRUITING NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT07570537 TubeClear System Evaluation in Pediatric Patients NOT_YET_RECRUITING NCT07561957 A Smart Phone Application to Improve Adoption of the 2024 Kidney Disease Improving Global Outcomes (KDIGO) Chronic Kidney Disease (CKD) Guidelines RECRUITING NCT06696365 iTBS for Alcohol Use Disorder TERMINATED

Related PubMed Literature

PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Other Devices by Navi Medical Technologies

K260929Neonav ECG Tip Location System

Related Devices (Code: LJS)

K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) K162443PowerPICC Provena CathetersC.R. Bard, Inc. K161496Turbo-Flo PICC SetsCook Incorporated K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex K153469Cathtong I PICC CatheterL&Z Us, Inc. K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, 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.

↑