Clearance Summary
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) received FDA 510(k) clearance under submission number K953034, sponsored by Ackrad Laboratories. 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 1995-08-29.
- Submission: K953034
- Applicant / Sponsor: Ackrad Laboratories
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1995-08-29
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.