Clearance Summary
MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 received FDA 510(k) clearance under submission number K080679, sponsored by Viasys Medsystems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2008-06-27.
- Submission: K080679
- Applicant / Sponsor: Viasys Medsystems
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2008-06-27
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.