Clearance Summary
Xtractor device received FDA 510(k) clearance under submission number K211679, sponsored by Xcardia Innovation , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-02-17.
- Submission: K211679
- Applicant / Sponsor: Xcardia Innovation , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1310
- Decision date: 2022-02-17
Classification & Regulation
This clearance is catalogued under FDA product code DRE and 21 CFR 870.1310, within the Cardiovascular review panel as a Class II device.