ENDOBRONCHIAL TWIN LUMEN TUBE— 510(k) K834565
Substantially EquivalentPortex, Inc.
FDA 510(k) clearance K834565 for ENDOBRONCHIAL TWIN LUMEN TUBE, Substantially Equivalent on 1984-01-17. Applicant: Portex, Inc.. Device class: 2.
Clearance details
- Applicant
- Portex, Inc.
- Product code
- Code BTS
- Device class
- Class 2
- Regulation
- 21 CFR 868.5720
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code BTS
product code BTS- Death
- 2
- Malfunction
- 877
- Total
- 879
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.