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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 the device name listed in this FDA 510(k) record. The listed applicant is Navi Medical Technologies. It received FDA 510(k) clearance on 2025-01-19 under 510(k) 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. The listed applicant is Navi Medical Technologies. The 510(k) number is K241910.

When did Neonav ECG Tip Location System receive FDA 510(k) clearance?

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

Who is the listed applicant for Neonav ECG Tip Location System?

The FDA 510(k) record lists Navi Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Navi Medical Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260929Neonav ECG Tip Location System

Related Devices (Code: LJS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum VascularK252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

Official Source

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