# K151313: ZelanteDVT Thrombectomy Set

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Sep 21, 2015 after 126 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: 12 generations back to K901627 (1990). 21 ancestors in all.
26 later devices descend from it; 2 cite it directly.
1 of 48 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111182: Angiojet Solent Omni Thrombectomy Set, Medrad, Inc. (2011) Summary page 4.

## Most influential descendants
- K193462: ClotTriever Thrombectomy System (2020), 21 descendants of its own
- K210190: ClotTriever Thrombectomy System (2021), 20 descendants of its own
- K210689: ClotTriever Thrombectomy System (2021), 19 descendants of its own
- K212632: ClotTriever Thrombectomy System (2021), 15 descendants of its own
- K223000: Artix BG (2023), 3 descendants of its own

## Indications for use
The ZelanteDVT™ Thrombectomy Set is intended for use with the AngioJet® Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from: • Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and • Upper extremity peripheral veins ≥ 6.0 mm in diameter. The ZelanteDVT Thrombectomy Set 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/K151313
Methodology: https://510kreport.com/methodology