FlowArt® Vial Access Device Vented— 510(k) K251715

Substantially Equivalent

Asset Medikal

FDA 510(k) clearance K251715 for FlowArt® Vial Access Device Vented, Substantially Equivalent on 2025-10-14. Applicant: Asset Medikal.

Clearance details

Applicant: Asset Medikal
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2025-06-04
Decision date: 2025-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Istanbul, TR

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.