Clearance Summary
PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 received FDA 510(k) clearance under submission number K131452, sponsored by St. Jude Medical Systems AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-09-05.
- Submission: K131452
- Applicant / Sponsor: St. Jude Medical Systems AB
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2870
- Decision date: 2013-09-05
Classification & Regulation
This clearance is catalogued under FDA product code DXO and 21 CFR 870.2870, within the Cardiovascular review panel as a Class II device.