# K250836: 14F Duo-Flow® Side X Side Double Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Aug 12, 2025 after 145 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
Longest line of descent: 2 generations back to K955002 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192807: Duo-Flow Side x Side Double Lumen Catheter, Medical Components, Inc. (dba MedComp) (2020) Summary page 5.

## Indications for use
The Duo-Flow@ Side X Side double lumen catheter is intended for short-term central venous access for hemodialysis, apheresis and infusion.

Source page: https://510kreport.com/device/K250836
Methodology: https://510kreport.com/methodology