# K213065: Distal Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Easycess Medical Co.,Ltd
- Decided: May 31, 2022 after 250 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: 8 generations back to K010954 (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)
- K150366: SOFIA 6F Catheter, MicroVention, Inc. (2015) Summary page 4.
- K131482: Sofia Distal Access Catheter, MicroVention, Inc. (2013) Summary page 4.
- K142014: Sofia Distal Access Catheter, MicroVention, Inc. (2014) Summary page 4.

## Indications for use
The Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.

Source page: https://510kreport.com/device/K213065
Methodology: https://510kreport.com/methodology