Clearance Summary
Barrier EasyWarm Active Self-Warming Blanket received FDA 510(k) clearance under submission number K232508, sponsored by Molnlycke Health Care Us, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-09-15.
- Submission: K232508
- Applicant / Sponsor: Molnlycke Health Care Us, LLC
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2023-09-15
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.