Clearance Summary
PTI ANNULOPLASTY RING(STERILE) received FDA 510(k) clearance under submission number K905175, sponsored by Pioneering Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1992-02-14.
- Submission: K905175
- Applicant / Sponsor: Pioneering Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3800
- Decision date: 1992-02-14
Classification & Regulation
This clearance is catalogued under FDA product code KRH and 21 CFR 870.3800, within the Cardiovascular review panel as a Class II device.