Disposable Double Lumen Endobronchial Tube— 510(k) K232529
Substantially EquivalentShenzhen Insighters Medical Technology Co., Ltd.
FDA 510(k) clearance K232529 for Disposable Double Lumen Endobronchial Tube, Substantially Equivalent on 2024-05-13. Applicant: Shenzhen Insighters Medical Technology Co., Ltd..
Clearance details
- Applicant
- Shenzhen Insighters Medical Technology Co., Ltd.
- Product code
- Code CBI
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.