# K201085: NeVa PV Thrombectomy Device

- Pathway: 510(k) (Traditional)
- Applicant: Vesalio
- Decided: Jan 15, 2021 after 267 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: 5 generations back to K832023 (1983). 17 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132281: ReVive PV (Peripheral Vasculature) Thrombectomy Device, Codman & Shurtleff, Inc. (2013) Summary page 4.

## Most influential descendants
- K254211: pVasc Net Mechanical Thrombectomy Device (2026), 0 descendants of its own
- K253407: NeVa PV Thrombectomy Device (2025), 0 descendants of its own

## Indications for use
The NeVa™ PV Thrombectomy Device is indicated for: The non-surgical removal of emboli and thrombi from peripheral blood vessels. Temporary use in peripheral vessel occlusion. Use with aspiration and with the injection or infusion of contrast media and other fluids.

Source page: https://510kreport.com/device/K201085
Methodology: https://510kreport.com/methodology