SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
FDA 510(k) clearance K052055 · decided 2006-10-26
Clearance details
- K-number
- K052055
- Device name
- SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
- Applicant
- Smisson-Cartledge Biomedical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-07-29
- Decision date
- 2006-10-26
- Days to decision
- 454 days
- Clearance type
- Traditional
- Product code
- LGZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 12 recall (Z-1258-2021) | Smisson-Cartledge Biomedical, LLC | 2021-03-26 |
| ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 12 recall (Z-1259-2021) | Smisson-Cartledge Biomedical, LLC | 2021-03-26 |
| ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 12 recall (Z-1260-2021) | Smisson-Cartledge Biomedical, LLC | 2021-03-26 |