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FDA 510(k)

L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters

K-Number: K230669 · 2023-11-30

ApplicantArgon Medical Devices
Decision Date2023-11-30
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices. It received FDA 510(k) clearance on 2023-11-30 under 510(k) number K230669. 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 L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters?

L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters is a medical device that received FDA 510(k) clearance on 2023-11-30. The listed applicant is Argon Medical Devices. The 510(k) number is K230669.

When did L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters receive FDA 510(k) clearance?

L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters received FDA 510(k) clearance on 2023-11-30, under 510(k) number K230669.

Who is the listed applicant for L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters?

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

What is the FDA product code for L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters?

The FDA product code for L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters is LJS.

Related Clinical Trials

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.

NCT07102160Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended TrackingRECRUITINGNCT06668766Single Lumen Midline Catheter vs Long Peripheral Intravenous Cather for Difficult Intravenous Access in the EDCOMPLETEDNCT07779317Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered NursesRECRUITING

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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