# K243534: Micro Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Zenith Vascular SciTech Limited
- Decided: Jul 30, 2025 after 257 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K974473 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210114: Rebar Micro Catheter, Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular (2021) Summary page 5.

## Indications for use
The Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.

Source page: https://510kreport.com/device/K243534
Methodology: https://510kreport.com/methodology