← Back to catalogue

Neonav ECG Tip Location System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241910

by Navi Medical Technologies

Identifiers

510(k) Number
K241910 FDA 510(k)
FDA Product Code
LJS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5970 FDA 510(k)
Regulation Number
880.5970 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Neonav ECG Tip Location System is a catheter, intravascular, therapeutic, long-term greater than 30 days device designed for real-time tip location and surveillance during central venous access device (CVAD) dwell time. It uses ECG signal analysis to detect misplacement during insertion and post-procedure migration in newborn and pediatric patients.

The system is supplied as a reusable or single-use component (implied by device type and clinical use) and is intended for use in general hospital settings. It has received FDA 510(k) clearance under product code LJS and regulation number 880.5970, with clearance granted on 2025-01-19 under traditional review. No MRI safety, sterility, storage, or size specifications are provided in the data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Products — Navi Medical Technologies, The Neonav® ECG Tip Location System Receives FDA 510 (k) Clearance, Navi Medical Technologies' Neonav® ECG Tip Location System Receives FDA ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Navi Medical Technologies

Sources (1)

  • FDA 510(k) K241910 24 fields · synced Sep 25, 2026