# K250775: Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System

- Pathway: 510(k) (Special)
- Applicant: Imperative Care, Inc.
- Decided: May 14, 2025 after 61 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: 9 generations back to K003410 (2001). 11 ancestors in all.
2 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)
- K223216: Symphony Thrombectomy System, Truvic Medical, Inc. (2023) Summary page 5.

## Most influential descendants
- 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. The Symphony 16F 82cm 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 16F 82cm 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/K250775
Methodology: https://510kreport.com/methodology