Clearance Summary
CHORD-X EPTFE SUTURE received FDA 510(k) clearance under submission number K121173, sponsored by On-Xlifetechnologies. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-08-16.
- Submission: K121173
- Applicant / Sponsor: On-Xlifetechnologies
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3470
- Decision date: 2012-08-16
Classification & Regulation
This clearance is catalogued under FDA product code PAW and 21 CFR 870.3470, within the Cardiovascular review panel as a Class II device.