MICROGARD II— 510(k) K111408

Name: FDA 510(k) clearance K111408
Creator: U.S. Food and Drug Administration
Published: 2011-10-17

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. Device class: 2.

Clearance details

Applicant: Carefusion Germany 234 GmbH
Product code: Code CAH
Device class: Class 2
Regulation: 21 CFR 868.5260
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 ↗

Recent devices under product code CAH

view all

K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled2026-05-15
K251583 — Ambu® Virobac II® Exhalation Filter2026-04-30
K241339 — Besmed Bacterial Filter and HMEF2024-11-14
K222917 — Breathing circuit bacterial/viral filter2024-02-15
K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)2023-09-16

More clearances from Carefusion Germany 234 GmbH

view all

K153654 — Sentry WEB SmartInterp2016-09-16
K150810 — Vyntus / SentrySuite Product Line2015-08-14
K142959 — Vyntus Walk2015-03-20
K141936 — MICROBLAB, MICROLOOP2014-12-29
K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE2014-08-22

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.