Clearance Summary
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT received FDA 510(k) clearance under submission number K141060, sponsored by On-X Life Technologies, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-06-06.
- Submission: K141060
- Applicant / Sponsor: On-X Life Technologies, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3470
- Decision date: 2014-06-06
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.