FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
K Number: K213089
·
Decision Nov 10, 2021
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
2
Review Days
47
Basic Information
- Device Name
- Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
- K Number
- K213089
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ivenix, Inc.
- Date Received
- September 24, 2021
- Decision Date
- November 10, 2021
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Ivenix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K183311 | Ivenix Infusion System (IIS) | Jun 7, 2019 | Substantially Equivalent |