# K082868: Mullins-X, Model 250X

- Pathway: 510(k) (Special)
- Applicant: NuMED, Inc.
- Decided: Oct 24, 2008 after 25 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041093 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041093: Numed Mullins X Pta Catheter, NuMED, Inc. (2004) Summary page 1.

## Indications for use
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. This catheter is not indicated for use in the coronary arteries, stent placement or stent redilation.

Source page: https://510kreport.com/device/K082868
Methodology: https://510kreport.com/methodology