K251318
- 510(k) number
- K251318
- Device name
- VariFuse Adjustable Infusion Catheter
- Applicant
- Argon Medical Devices, Inc. TX · US
- Product code
- QEY — Mechanical Thrombolysis Catheter
- Decision date
- 2026-01-20
- Date received
- 2025-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.8 MB · U.S. public domain
Also available from FDA: K251318.pdf
Official FDA record: K251318
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.