Clearance Summary
MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE received FDA 510(k) clearance under submission number K890988, sponsored by Pace Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-08-25.
- Submission: K890988
- Applicant / Sponsor: Pace Medical
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3680
- Decision date: 1989-08-25
Classification & Regulation
This clearance is catalogued under FDA product code LDF and 21 CFR 870.3680, within the Cardiovascular review panel as a Class II device.