# K123235: Equaflow Multivalve Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Feb 14, 2013 after 121 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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 K940634 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964868: 2.9F Cragg-Mcnamara Valved Infusion Catheter, Micro Therapeutics, Inc. (1997) Summary page 1.
- K961763: Pulse*Spray Infusion System, Angiodynamics, Div. E-Z-Em, Inc. (1996) Summary page 1.

## Indications for use
The EquaFlow Multivalve Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents into the general vasculature. It is not intended for coronary, pediatric or neonatal use.

Source page: https://510kreport.com/device/K123235
Methodology: https://510kreport.com/methodology