lntravascular Administration Sets with Stopcock and Manifold— 510(k) K223175

Substantially Equivalent

Baxter Healthcare Corporation

FDA 510(k) clearance K223175 for lntravascular Administration Sets with Stopcock and Manifold, Substantially Equivalent on 2023-03-10. Applicant: Baxter Healthcare Corporation.

Clearance details

Applicant: Baxter Healthcare Corporation
Product code: Code FMG
Advisory panel: General Hospital
Date received: 2022-10-11
Decision date: 2023-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.