K233909
- 510(k) number
- K233909
- Device name
- Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister
- Applicant
- Argon Medical Devices, Inc. TX · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2024-03-28
- Date received
- 2023-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233909.pdf
Official FDA record: K233909
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.