# K261523: Vertex™ Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Jupiter Endovascular
- Decided: Aug 4, 2026 after 89 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: 11 generations back to K003410 (2001). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252057: Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System, Imperative Care, Inc. (2025) Summary page 5.

## Indications for use
The Vertex Thrombectomy System is indicated for use in the pulmonary arteries for: *The non-surgical removal of emboli and thrombi. *Injection, infusion, and/or aspiration of contrast media and other fluids. The Vertex Thrombectomy System is intended for the treatment of pulmonary embolism.

Source page: https://510kreport.com/device/K261523
Methodology: https://510kreport.com/methodology