Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector— 510(k) K213089

Substantially Equivalent

Ivenix, 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..

Clearance details

Applicant: Ivenix, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2021-09-24
Decision date: 2021-11-10
Decision: Substantially Equivalent
Clearance type: Special
Location: North Andover, MA, US

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Adverse 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, 2020-01-01 through 2026-04-23. 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.