APA Oxy Blade— 510(k) K191602
Substantially EquivalentVenner Medical (Singapore) Pte, Ltd.
FDA 510(k) clearance K191602 for APA Oxy Blade, Substantially Equivalent on 2019-08-02. Applicant: Venner Medical (Singapore) Pte, Ltd.. Device class: 1.
Clearance details
- Applicant
- Venner Medical (Singapore) Pte, Ltd.
- Product code
- Code CCW
- Device class
- Class 1
- Regulation
- 21 CFR 868.5540
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code CCW
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- 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
- K110631 — VENNER TRACHEAL SEAL MONITOR
- K100950 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
- K093135 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
Adverse events under product code CCW
product code CCW- Death
- 31
- Injury
- 136
- Malfunction
- 3,703
- Other
- 1
- Total
- 3,871
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.