Cleared Traditional

Neonav ECG Tip Location System

K241910 · Navi Medical Technologies · Cardiovascular
Jan 2025
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K241910 is an FDA 510(k) clearance for the Neonav ECG Tip Location System, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Navi Medical Technologies (Carlton, AU). The FDA issued a Cleared decision on January 19, 2025, 202 days after receiving the submission on July 1, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K241910 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2024
Decision Date January 19, 2025
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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