K202461 is an FDA 510(k) clearance for the ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Smisson-Cartledge Biomedical, LLC (Macon, US). The FDA issued a Cleared decision on August 12, 2022, 715 days after receiving the submission on August 27, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K202461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2020 |
| Decision Date | August 12, 2022 |
| Days to Decision | 715 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LGZ - Warmer, Thermal, Infusion Fluid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |