# K182071: Multi-Sideport Catheter Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Apr 25, 2019 after 267 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904788 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991619: FOUNTAIN Infusion Catheter and Occluding Guide Wire, Merit Medical Systems, Inc. (1999) Summary page 4.

## Indications for use
The Multi-Sideport Catheter Infusion Set is intended to administer infusions of various therapeutic solutions and contrast media into the peripheral vasculature.

Source page: https://510kreport.com/device/K182071
Methodology: https://510kreport.com/methodology