# K983511: Soft-Line IJ Double Lumen Catheter 11.5FR X 12CM, Soft-Line IJ Double Lumen Catheter 11.5FR X 15CM, Soft-Line Lumen Cath

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Jun 8, 1999 after 244 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jul 12, 2018 · Class II · Z-2937-2018: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) t
- Jul 12, 2018 · Class II · Z-2942-2018: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) t
- Jul 12, 2018 · Class II · Z-2935-2018: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) t
- Jul 12, 2018 · Class II · Z-2934-2018: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) t
- Jul 12, 2018 · Class II · Z-2936-2018: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) t
- Jul 12, 2018 · Class II · Z-2938-2018: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) t
- Jul 12, 2018 · Class II · Z-2941-2018: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) t
- Jul 12, 2018 · Class II · Z-2940-2018: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) t
- Jul 12, 2018 · Class II · Z-2939-2018: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) t
- Jul 12, 2018 · Class II · Z-2933-2018: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) t
- Jul 12, 2018 · Class II · Z-2932-2018: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) t

## Indications for use
The Medcomp Soft-Line and Raulerson/Duo-Flow Double Lumen Internal Jugular Catheters are designed for acute hemodialysis and apheresis. They may be inserted percutaneously and are ideally placed in the jugular vein.

Source page: https://510kreport.com/device/K983511
Methodology: https://510kreport.com/methodology