# K221391: WOLF Thrombectomy™ SmartClaw Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Devoro Medical, Inc.
- Decided: Nov 10, 2022 after 181 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: 7 generations back to K832023 (1983). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210911: WOLF Thrombectomy System, 14F, Devoro Medical, Inc. (2021) Summary page 4.

## Most influential descendants
- K241207: SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) (2024), 0 descendants of its own

## Indications for use
The WOLF Thrombectomy SmartClaw Catheter, in conjunction with the WOLF Thrombectomy Aspiration Sheath, 14F, is indicated for: • the non-surgical removal of thrombi and emboli from arterial and venous blood vessels in the peripheral vasculature. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

Source page: https://510kreport.com/device/K221391
Methodology: https://510kreport.com/methodology