Clearance Summary
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System received FDA 510(k) clearance under submission number K202461, sponsored by Smisson-Cartledge Biomedical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2022-08-12.
- Submission: K202461
- Applicant / Sponsor: Smisson-Cartledge Biomedical, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2022-08-12
Classification & Regulation
This clearance is catalogued under FDA product code LGZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.