FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.— 510(k) K800147

Substantially Equivalent

Usifroid

FDA 510(k) clearance K800147 for FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC., Substantially Equivalent on 1980-04-24. Applicant: Usifroid.

Clearance details

Applicant: Usifroid
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 1980-01-22
Decision date: 1980-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

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.