Ambu® Virobac II® Exhalation Filter— 510(k) K251583
Substantially EquivalentAmbu A/S
FDA 510(k) clearance K251583 for Ambu® Virobac II® Exhalation Filter, Substantially Equivalent on 2026-04-30. Applicant: Ambu A/S. Device class: 2.
Clearance details
- Applicant
- Ambu A/S
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ballerup, DK
Recent devices under product code CAH
view all- K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
- K241339 — Besmed Bacterial Filter and HMEF
- K222917 — Breathing circuit bacterial/viral filter
- K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
- K223258 — TNI Clear-Guard 3 angled breathing filter (1545020)
More clearances from Ambu A/S
view all- K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
- K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)
- K240849 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2
- K240848 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance
- K242108 — Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance
Adverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . 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.