VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE— 510(k) K093135
Substantially EquivalentVenner Medical (Singapore) Pte, Ltd.
FDA 510(k) clearance K093135 for VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE, Substantially Equivalent on 2010-04-02. Applicant: Venner Medical (Singapore) Pte, Ltd..
Clearance details
- Applicant
- Venner Medical (Singapore) Pte, Ltd.
- Product code
- Code BTR
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Adverse events under product code BTR
product code BTR- Death
- 92
- Injury
- 1,263
- Malfunction
- 7,475
- Other
- 2
- Total
- 8,832
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.