510(k) K241910

Neonav ECG Tip Location System by Navi Medical Technologies — Product Code LJS

K241910 is an FDA 510(k) premarket notification submitted by Navi Medical Technologies for the device "Neonav ECG Tip Location System". The FDA issued a decision of Substantially Equivalent on January 19, 2025. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Navi Medical Technologies has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2025
Date Received
July 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type