Clearance Summary
Mistral-Air Warming Unit received FDA 510(k) clearance under submission number K171234, sponsored by The Surgical Company International BV (As the 37company). The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-05-26.
- Submission: K171234
- Applicant / Sponsor: The Surgical Company International BV (As the 37company)
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2017-05-26
Classification & Regulation
This clearance is catalogued under FDA product code DWJ and 21 CFR 870.5900, within the Cardiovascular review panel as a Class II device.