# K240711: Zipline Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Perfuze, Ltd.
- Decided: Oct 17, 2024 after 216 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: 1 generation back to K182512 (2018). 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)
- K182512: Route 92 Medical Delivery Catheter, Route 92 Medical, Inc. (2018) Summary page 5.

## Indications for use
The Zipline Access Catheter is indicated to facilitate the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

Source page: https://510kreport.com/device/K240711
Methodology: https://510kreport.com/methodology