FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
InVera Infusion Device
K Number: K250794
·
Decision Mar 12, 2026
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
1
Review Days
363
Basic Information
- Device Name
- InVera Infusion Device
- K Number
- K250794
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invera Medical
- Date Received
- March 14, 2025
- Decision Date
- March 12, 2026
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRA), ordered by most recent decision date.
Verge Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
TruSelect 2.6 Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
FDA 510(k)
FDA Class 2
·Cardiovascular
Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
FDA 510(k)
FDA Class 2
·Cardiovascular
ScleroSafe 150 mm, ScleroSafe 350 mm
FDA 510(k)
FDA Class 2
·Cardiovascular