# K251185: Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)

- Pathway: 510(k) (Traditional)
- Applicant: Intervene
- Decided: Oct 22, 2025 after 189 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 5.

## Indications for use
The Recana Thrombectomy Catheter System is indicated for: • The non-surgical removal of thrombi and emboli from veins. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vein. The Recana Thrombectomy Catheter System is indicated for use in peripheral venous vasculature.

Source page: https://510kreport.com/device/K251185
Methodology: https://510kreport.com/methodology