# K221827: Mais Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Saudi Mais Co. For Medical Products
- Decided: Jun 23, 2023 after 365 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 25 ancestors in all.
No later device cites it as a predicate yet.
4 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190855: BD Acute Central Line, Bard Access Systems, Inc. (Bard Has Joined Bd) (2019) Summary page 5.

## Indications for use
Mais central venous catheters are indicated to provide short-term access (<30 days) to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and central venous pressure monitoring.

Source page: https://510kreport.com/device/K221827
Methodology: https://510kreport.com/methodology