Ivenix Infusion System (IIS)— 510(k) K183311

Substantially Equivalent

Ivenix, Inc.

FDA 510(k) clearance K183311 for Ivenix Infusion System (IIS), Substantially Equivalent on 2019-06-07. Applicant: Ivenix, Inc..

Clearance details

Applicant: Ivenix, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2018-11-29
Decision date: 2019-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Andover, MA, US

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.