ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.— 510(k) K914364

Substantially Equivalent

North American Technical Services Corp.

FDA 510(k) clearance K914364 for ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO., Substantially Equivalent on 1992-09-10. Applicant: North American Technical Services Corp..

Clearance details

Applicant: North American Technical Services Corp.
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 1991-10-01
Decision date: 1992-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Jefferson, NY, 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.