# K242420: pNOVUS 21 Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Phenox, Ltd.
- Decided: Nov 12, 2024 after 89 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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 K221279 (2022). 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)
- K221279: pNOVUS 21 Microcatheter, Phenox, Ltd. (2022) Summary page 5.

## Indications for use
The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. It is not intended for use in peripheral or coronary vasculature.

Source page: https://510kreport.com/device/K242420
Methodology: https://510kreport.com/methodology