# K261176: Zoom 4S Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Imperative Care, Inc.
- Decided: Aug 28, 2026 after 140 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- 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: 10 generations back to K003880 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202752: AXS Vecta 46 Intermediate Catheter, Stryker Neurovascular (2021) Summary page 5.

## Indications for use
The Zoom 4S Catheter is indicated for the introduction of interventional devices into the neuro vasculature.

Source page: https://510kreport.com/device/K261176
Methodology: https://510kreport.com/methodology