CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900— 510(k) K063061
Substantially EquivalentViasys Medsystems
FDA 510(k) clearance K063061 for CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900, Substantially Equivalent on 2007-04-02. Applicant: Viasys Medsystems. Device class: 2.
Clearance details
- Applicant
- Viasys Medsystems
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wheeling, IL, US
Recent devices under product code KNT
view allMore clearances from Viasys Medsystems
view all- K081725 — ENTERAL PUMP SET, MODEL 20-1010
- K080679 — MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
- K043044 — ANTI-I.V. ENTERAL FEEDING SYSTEM
- K050309 — PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
- K043004 — STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031
Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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.