Clearance Summary
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter received FDA 510(k) clearance under submission number K192302, sponsored by Covidien, LLC. 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 2020-01-17.
- Submission: K192302
- Applicant / Sponsor: Covidien, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2020-01-17
Classification & Regulation
This clearance is catalogued under FDA product code MPB and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.