MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS— 510(k) K020289

Substantially Equivalent

Machnet BV

FDA 510(k) clearance K020289 for MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS, Substantially Equivalent on 2002-04-24. Applicant: Machnet BV.

Clearance details

Applicant: Machnet BV
Product code: Code LNH
Advisory panel: Radiology
Date received: 2002-01-28
Decision date: 2002-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.