Clearance Summary
BT-CATH received FDA 510(k) clearance under submission number K101535, sponsored by Utah Medical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2011-01-11.
- Submission: K101535
- Applicant / Sponsor: Utah Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2011-01-11
Classification & Regulation
This clearance is catalogued under FDA product code OQY and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.