MEDTRONIC 3625 SCREENER SYSTEM— 510(k) K913442

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K913442 for MEDTRONIC 3625 SCREENER SYSTEM, Substantially Equivalent on 1991-11-22. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code GZB
Advisory panel: Neurology
Date received: 1991-08-02
Decision date: 1991-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code GZB

product code GZB

Death: 4
Injury: 1,879
Other: 2
Total: 1,885

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.