MICROGARD II— 510(k) K111408

Substantially Equivalent

Carefusion Germany 234 GmbH

FDA 510(k) clearance K111408 for MICROGARD II, Substantially Equivalent on 2011-10-17. Applicant: Carefusion Germany 234 GmbH.

Clearance details

Applicant: Carefusion Germany 234 GmbH
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2011-05-19
Decision date: 2011-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoechberg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.