FDA 510(k)

Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler

K-Number: K260080 · 2026-10-09

Decision Date2026-10-09

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 2026-10-09 under 510(k) number K260080. 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 Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler?

Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler is a medical device that received FDA 510(k) clearance on 2026-10-09. The listed applicant is Medical Components, Inc.. The 510(k) number is K260080.

When did Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler receive FDA 510(k) clearance?

Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler received FDA 510(k) clearance on 2026-10-09, under 510(k) number K260080.

Who is the listed applicant for Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler?

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

What is the FDA product code for Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler?

The FDA product code for Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler is LJS.

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Related Devices (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo 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 Vascular K252792PM2™ 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.