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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K260929
Device Name Neonav ECG Tip Location System
Applicant
Navi Medical Technologies
Level 2, 700 Swanston St.
Carlton,  AU 3053
Applicant Contact Zorana Mayooran
Correspondent
Navi Medical Technologies
Level 2, 700 Swanston St.
Carlton,  AU 3053
Correspondent Contact Zorana Mayooran
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/20/2026
Decision Date 04/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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