FlowArt Valve for Vial Access— 510(k) K232987

Substantially Equivalent

Asset Medikal Tasarim Sanayi VE Ticaret A.S.

FDA 510(k) clearance K232987 for FlowArt Valve for Vial Access, Substantially Equivalent on 2024-06-26. Applicant: Asset Medikal Tasarim Sanayi VE Ticaret A.S..

Clearance details

Applicant: Asset Medikal Tasarim Sanayi VE Ticaret A.S.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2023-09-22
Decision date: 2024-06-26
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.