SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200— 510(k) K052055

Substantially Equivalent

Smisson-Cartledge Biomedical, LLC

FDA 510(k) clearance K052055 for SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200, Substantially Equivalent on 2006-10-26. Applicant: Smisson-Cartledge Biomedical, LLC.

Clearance details

Applicant: Smisson-Cartledge Biomedical, LLC
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2005-07-29
Decision date: 2006-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

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Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.