# K242588: COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)

- Pathway: 510(k) (Traditional)
- Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.
- Decided: Jan 7, 2025 after 130 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 11 generations back to K001992 (2000). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231608: Teleport XT Microcatheter, OrbusNeich Medical (Shenzhen) Co., Ltd. (2024) Summary page 5.

## Indications for use
The COREPASS FLEX/CONTROL microcatheters are indicated for: • supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature (not intended for neurovasculature). • exchanging guidewires in the coronary and peripheral vasculature. • the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

Source page: https://510kreport.com/device/K242588
Methodology: https://510kreport.com/methodology