# K212719: Micro Catheter and Guidewire System

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Hengrui Hongyuan Medical Co., Ltd.
- Decided: Apr 11, 2022 after 227 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 K961923 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171665: Microcatheter and guide-wire system, Suzhou Hengrui Disheng Medical Co., Ltd. (2018) Summary page 4.

## Indications for use
The Micro Catheter and Guidewire System is intended for the infusion of contrast media into the peripheral vessels. The Micro Catheter and Guidewire system is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The system should not be used in cerebral vessels.

Source page: https://510kreport.com/device/K212719
Methodology: https://510kreport.com/methodology