Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System— 510(k) K252057
Substantially EquivalentImperative 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.. Device class: 2.
Clearance details
- Applicant
- Imperative Care, Inc.
- Product code
- Code QEW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Campbell, CA, US
Recent devices under product code QEW
view allMore clearances from Imperative Care, Inc.
view allAdverse events under product code QEW
product code QEW- Death
- 126
- Injury
- 282
- Malfunction
- 820
- Total
- 1,228
Source: openFDA MAUDE database, through . 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.