K250775
- 510(k) number
- K250775
- Device name
- Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System
- Applicant
- Imperative Care, Inc. CA · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2025-05-14
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250775.pdf
Official FDA record: K250775
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.