# K202218: ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Oct 2, 2020 after 57 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: 13 generations back to K901627 (1990). 22 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151313: ZelanteDVT Thrombectomy Set, Boston Scientific Corporation (2015) Summary page 4.

## Most influential descendants
- K220780: ROVO Mechanical Thrombectomy Device (2023), 1 descendant of its own
- K253730: RoVo Mechanical Thrombectomy System (2026), 0 descendants of its own
- K243549: JETi Hydrodynamic Thrombectomy System (2025), 0 descendants of its own

## Indications for use
The ZelanteDVT Thrombectomy System, which includes the ZelanteDVT Thrombectomy Set and the ClotHunter Helical Rotation Device, is intended for use with the AngioJet Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from: liofemoral and lower extremity veins > 6.0 mm in diameter and Upper extremity peripheral veins > 6.0 mm in diameter. The ZelanteDVT Thrombectomy System is also intended for use with the AngioJet Ultra Power Pulse technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Source page: https://510kreport.com/device/K202218
Methodology: https://510kreport.com/methodology