# K252057: Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Imperative Care, Inc.
- Decided: Aug 28, 2025 after 58 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: 10 generations back to K003410 (2001). 12 ancestors in all.
1 later device descends 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)
- K250775: Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System, Imperative Care, Inc. (2025) Summary page 5.

## Most influential descendants
- 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 and for the treatment of pulmonary embolism. 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/K252057
Methodology: https://510kreport.com/methodology