ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System— 510(k) K202461
Substantially EquivalentSmisson-Cartledge Biomedical, LLC
FDA 510(k) clearance K202461 for ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System, Substantially Equivalent on 2022-08-12. Applicant: Smisson-Cartledge Biomedical, LLC.
Clearance details
- Applicant
- Smisson-Cartledge Biomedical, LLC
- Product code
- Code LGZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Macon, GA, US
Adverse events under product code LGZ
product code LGZ- Death
- 16
- Malfunction
- 5,916
- Other
- 1
- Total
- 5,933
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.