Clearance Summary
MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 received FDA 510(k) clearance under submission number K000767, sponsored by Memcath Technologies, 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 2000-06-05.
- Submission: K000767
- Applicant / Sponsor: Memcath Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2000-06-05
Classification & Regulation
This clearance is catalogued under FDA product code KNY and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.