# K214114: Prodigy Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Truvic Medical, Inc.
- Decided: Apr 6, 2022 after 97 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: 8 generations back to K003410 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142870: Penumbra Embolectomy Aspiration System [INDIGO Aspiration System], Penumbra, Inc. (2015) Summary page 4.

## Indications for use
The Prodigy™ Thrombectomy System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. Not for use in the coronaries, pulmonary vasculature, or the neurovasculature

Source page: https://510kreport.com/device/K214114
Methodology: https://510kreport.com/methodology