# K980438: 11.5F X 6 (15CM) Duo-Split Catheter MCDS116MT, 11.5F X 8 (20CM) Duo-Split Catheter MCDS118MT

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Jun 10, 1999 after 491 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- 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.

## Indications for use
The Medcomp Duo-Split Double Lumen Catheter is designed for acute hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian or femoral vein, the internal jugular vein is the preferred site.

Source page: https://510kreport.com/device/K980438
Methodology: https://510kreport.com/methodology