Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector— 510(k) K213089
Substantially EquivalentIvenix, Inc.
FDA 510(k) clearance K213089 for Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector, Substantially Equivalent on 2021-11-10. Applicant: Ivenix, Inc.. Device class: 2.
Clearance details
- Applicant
- Ivenix, Inc.
- Product code
- Product code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- North Andover, MA, US
Recent devices under product code FPA
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- K251375 — PuraCath Firefly Needleless Connector IT (9005)
More clearances from Ivenix, Inc.
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.