# K234034: VenaCore Thrombectomy Catheter (46-101)

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: Feb 9, 2024 after 51 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: 18 generations back to K901627 (1990). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223609: RevCore™ Thrombectomy Catheter., Inari Medical, Inc. (2023) Summary page 4.

## Indications for use
The VenaCore Thrombectomy Catheter is indicated for: • The non-surgical removal of thrombi and emboli from blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels. The VenaCore Thrombectomy Catheter is intended for use in the peripheral vasculature.

Source page: https://510kreport.com/device/K234034
Methodology: https://510kreport.com/methodology