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.. Device class: 2.
Clearance details
- Applicant
- Venner Medical (Singapore) Pte, Ltd.
- Product code
- Code BTR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5730
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
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More clearances from Venner Medical (Singapore) Pte, Ltd.
view all- K192511 — Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm
- K192120 — Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tube) 7 mm, Venner PneuX ETT (Endotracheal Tube) 8 mm, Venner PneuX ETT (Endotracheal Tube) 9 mm
- K191602 — APA Oxy Blade
- K110631 — VENNER TRACHEAL SEAL MONITOR
- K100950 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
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.