Clearance Summary
SIB CATHETER, MODEL 61-7005 received FDA 510(k) clearance under submission number K021272, sponsored by Ackrad Laboratories. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2002-05-21.
- Submission: K021272
- Applicant / Sponsor: Ackrad Laboratories
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2002-05-21
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.