MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855— 510(k) K012052

Substantially Equivalent

Medtronic PS Medical

FDA 510(k) clearance K012052 for MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855, Substantially Equivalent on 2002-02-11. Applicant: Medtronic PS Medical.

Clearance details

Applicant: Medtronic PS Medical
Product code: Code JXG
Advisory panel: Neurology
Date received: 2001-07-02
Decision date: 2002-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, 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.