MEDTRONIC #1992-2 DUAL RATE TRANSMITTER— 510(k) K820988

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K820988 for MEDTRONIC #1992-2 DUAL RATE TRANSMITTER, Substantially Equivalent on 1982-06-23. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code GZB
Advisory panel: Neurology
Date received: 1982-04-07
Decision date: 1982-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.