K260028
- 510(k) number
- K260028
- Device name
- CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
- Applicant
- Argon Medical Devices, Inc. TX · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2026-02-05
- Date received
- 2026-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K260028.pdf
Official FDA record: K260028
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.