# K253359: Zenith Distal Access Long Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Zenith Vascular SciTech Limited
- Decided: May 22, 2026 after 234 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: 6 generations back to K010954 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111380: Neuron Max System, Penumbra, Inc. (2011) Summary page 5.

## Indications for use
The Zenith Distal Access Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K253359
Methodology: https://510kreport.com/methodology