FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VariFuse Adjustable Infusion Catheter
K Number: K251318
·
Decision Jan 20, 2026
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
70
Applicant Total
20
Review Days
266
Basic Information
- Device Name
- VariFuse Adjustable Infusion Catheter
- K Number
- K251318
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Argon Medical Devices, Inc.
- Date Received
- April 29, 2025
- Decision Date
- January 20, 2026
- Product Code
- QEY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | FDA class 2 | Cardiovascular |
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