Clearance Summary
DUAL-LUMEN CATHETER received FDA 510(k) clearance under submission number K024165, sponsored by Bistech, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2003-01-10.
- Submission: K024165
- Applicant / Sponsor: Bistech, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2003-01-10
Classification & Regulation
This clearance is catalogued under FDA product code EOQ and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.