DeviceClearance

Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler— 510(k) K260080

Substantially Equivalent

Medical Components, Inc.

FDA 510(k) clearance K260080 for Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler, Substantially Equivalent on 2026-10-09. Applicant: Medical Components, Inc.. Device class: 2.

Summary

This clearance covers two items from Medical Components: the Pro-Line XL Power Injectable Central Venous Catheter and the Pro-Line XL Tunneler. Both sit under LJS, long-term intravascular therapeutic catheters (more than 30 days). The name says the catheter is power injectable; the record gives no pressure or flow ratings.

Class II, 21 CFR 880.5970. The General Hospital panel reviewed it as a Traditional 510(k).

Medical Components filed from Harleysville, Pennsylvania. Review took 270 days (January 12 to October 9, 2026). The record doesn't show how much of that was hold time.

Clearance details

Applicant
Medical Components, Inc.
Product code
Product code LJS
Device class
Class 2
Regulation
21 CFR 880.5970
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Harleysville, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LJS

product code LJS
Death
31
Injury
2,791
Malfunction
18,374
Other
5
Total
21,201

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.