Clearance Summary
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY received FDA 510(k) clearance under submission number K030983, sponsored by Deltec, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-04-25.
- Submission: K030983
- Applicant / Sponsor: Deltec, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2003-04-25
Classification & Regulation
This clearance is catalogued under FDA product code MSD and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.