Clearance Summary
D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW received FDA 510(k) clearance under submission number K063355, sponsored by Novosci Corp.. 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 2007-07-27.
- Submission: K063355
- Applicant / Sponsor: Novosci Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2007-07-27
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.