# K231218: Distal Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Accumedical Beijing, Ltd.
- Decided: Jan 19, 2024 after 266 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: 2 generations back to K110055 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161152: Navien Intracranial Support Catheter, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2016) Summary page 5.

## Indications for use
The Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Source page: https://510kreport.com/device/K231218
Methodology: https://510kreport.com/methodology