# K223216: Symphony Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Truvic Medical, Inc.
- Decided: Feb 23, 2023 after 129 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.
3 later devices descend from it; 1 cites it directly.
0 of 14 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.

## Most influential descendants
- K250775: Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System (2025), 2 descendants of its own
- K252057: Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (2025), 1 descendant of its own
- K261523: Vertex™ Thrombectomy System (2026), 0 descendants of its own

## Indications for use
The Symphony Thrombectomy System is intended for: • The non-surgical removal of fresh, soft emboli and thrombi from blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Symphony Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.

Source page: https://510kreport.com/device/K223216
Methodology: https://510kreport.com/methodology