K234073
- 510(k) number
- K234073
- Device name
- ICE Aspiration System
- Applicant
- Expanse Medical, Inc. CA · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2024-04-19
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K234073.pdf
Official FDA record: K234073
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.