MODELS 3987 AND 3988 RESUME LEAD FOR PNS— 510(k) K920567

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K920567 for MODELS 3987 AND 3988 RESUME LEAD FOR PNS, Substantially Equivalent on 1992-05-20. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code GZF
Advisory panel: Neurology
Date received: 1992-02-07
Decision date: 1992-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code GZF

product code GZF

Death: 10
Injury: 2,410
Other: 1
Total: 2,421

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.