Clearance Summary
KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER received FDA 510(k) clearance under submission number K973546, sponsored by Kendall Healthcare Products Co. Div.Of Tyco Health. 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 1997-11-07.
- Submission: K973546
- Applicant / Sponsor: Kendall Healthcare Products Co. Div.Of Tyco Health
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1997-11-07
Classification & Regulation
This clearance is catalogued under FDA product code EZD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.