MixJect® Transfer Device— 510(k) K230464

Substantially Equivalent

West Pharma. Services IL, Ltd.

FDA 510(k) clearance K230464 for MixJect® Transfer Device, Substantially Equivalent on 2023-05-22. Applicant: West Pharma. Services IL, Ltd..

Clearance details

Applicant: West Pharma. Services IL, Ltd.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2023-02-21
Decision date: 2023-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Anana Central, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.