Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable— 510(k) K203749
Substantially EquivalentAmbu A/S
FDA 510(k) clearance K203749 for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable, Substantially Equivalent on 2021-05-03. Applicant: Ambu A/S. Device class: 2.
Clearance details
- Applicant
- Ambu A/S
- Product code
- Code CBI
- Device class
- Class 2
- Regulation
- 21 CFR 868.5740
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ballerup, DK
Recent devices under product code CBI
view allMore 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)
- K251583 — Ambu® Virobac II® Exhalation Filter
- 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
Adverse events under product code CBI
product code CBI- Death
- 4
- Malfunction
- 594
- Total
- 598
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 →
Recalls naming K203749
K-number listed on FDA's recall record- Z-0261-2025 — Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
- Z-1420-2022 — Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203749.
Data sourced from openFDA. This site is unofficial and independent of the FDA.