K232679
- 510(k) number
- K232679
- Device name
- Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister
- Applicant
- Argon Medical Devices, Inc. TX · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2024-01-19
- Date received
- 2023-09-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232679.pdf
Official FDA record: K232679
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.