Vial Adapter Ø20 mm— 510(k) K190149

Substantially Equivalent

Avenir Performance Europeenne Medical (Apem)

FDA 510(k) clearance K190149 for Vial Adapter Ø20 mm, Substantially Equivalent on 2019-10-15. Applicant: Avenir Performance Europeenne Medical (Apem).

Clearance details

Applicant: Avenir Performance Europeenne Medical (Apem)
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2019-01-29
Decision date: 2019-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Château-Landon, FR

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.