Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System— 510(k) K252057

Substantially Equivalent

Imperative Care, Inc.

FDA 510(k) clearance K252057 for Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System, Substantially Equivalent on 2025-08-28. Applicant: Imperative Care, Inc..

Clearance details

Applicant: Imperative Care, Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2025-07-01
Decision date: 2025-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campbell, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.