# K230743: ICHOR 14F Embolectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Ichor
- Decided: Sep 5, 2023 after 173 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: 8 generations back to K832023 (1983). 23 ancestors in all.
No later device cites it as a predicate yet.
3 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182531: ClotTriever Thrombectomy System, Inari Medical (2018) Summary page 4.
- K182167: The ICHOR Panacea Vascular Embolectomy Catheter System, Ichor Vascular, Inc. (2018) Summary page 4.

## Indications for use
The ICHOR 14F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from venous blood vessels. The System is intended for the peripheral vasculature and is not intended for use in the coronary or neurovasculature.

Source page: https://510kreport.com/device/K230743
Methodology: https://510kreport.com/methodology
