# K223891: Cobra Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Endovascular Engineering
- Decided: Feb 15, 2023 after 50 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K901627 (1990). 55 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 58 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212632: ClotTriever Thrombectomy System, Inari Medical, Inc. (2021) Summary page 4.
- K211798: Cleaner Plus Thrombectomy System, Argon Medical Devices, Inc. (2022) Summary page 4.

## Most influential descendants
- K252956: Helo Thrombectomy System (2025), 1 descendant of its own
- K261800: Helo Max Thrombectomy System (HEL2090) (2026), 0 descendants of its own

## Indications for use
The Cobra Catheter System is indicated for: • The non-surgical removal of thrombi and emboli from venous vasculature. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from the venous vasculature.

Source page: https://510kreport.com/device/K223891
Methodology: https://510kreport.com/methodology