# K210530: WOLF Thrombectomy System, 6F

- Pathway: 510(k) (Traditional)
- Applicant: Devoro Medical, Inc.
- Decided: Aug 27, 2021 after 184 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: 6 generations back to K832023 (1983). 19 ancestors in all.
No later device cites it as a predicate yet.
3 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182835: WOLF Thrombectomy Device, 880 Medical, LLC (2019) Summary page 4.
- K200101: WOLF Thrombectomy V System, Devoro Medical, Inc. (2020) Summary page 4.

## Indications for use
The WOLF Thrombectomy System, 6F is indicated for the nonsurgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature. The device is intended for single use only.

Source page: https://510kreport.com/device/K210530
Methodology: https://510kreport.com/methodology