Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors— 510(k) K143018
Substantially EquivalentCovidien
FDA 510(k) clearance K143018 for Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors, Substantially Equivalent on 2015-04-02. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- Product code
- Code PIF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
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Adverse events under product code PIF
product code PIF- Death
- 13
- Injury
- 122
- Other
- 1
- Total
- 136
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.