Clearance Summary
SF SH CATHETER, MODEL R65-945 received FDA 510(k) clearance under submission number K013437, sponsored by A & A Medical, 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 2001-11-19.
- Submission: K013437
- Applicant / Sponsor: A & A Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2001-11-19
Classification & Regulation
This clearance is catalogued under FDA product code LKF and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.