AMERICAN HEYER-SCHULTE LOW PROFILE VALVE— 510(k) K802586

Substantially Equivalent

American Heyer Schulte

FDA 510(k) clearance K802586 for AMERICAN HEYER-SCHULTE LOW PROFILE VALVE, Substantially Equivalent on 1980-12-18. Applicant: American Heyer Schulte.

Clearance details

Applicant: American Heyer Schulte
Product code: Code JXG
Advisory panel: Neurology
Date received: 1980-10-20
Decision date: 1980-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.