# K230669: L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices
- Decided: Nov 30, 2023 after 265 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925979 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091670: BD L-Cath Single and Dual Lument Catheters, Midline Catheter, Becton, Dickinson & CO (2009) Summary page 5.

## Recalls of this device
- Jun 15, 2026 · Class II · Z-2804-2026: Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at th
- Jun 15, 2026 · Class II · Z-2803-2026: Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at th
- Jun 14, 2024 · Class II · Z-2638-2024: Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.

## Indications for use
The L-Cath Single and Dual Lumen Catheters and the L-Cath Midline Catheters are indicated for short or long term peripheral access to the central venous system for the administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously.

Source page: https://510kreport.com/device/K230669
Methodology: https://510kreport.com/methodology