MEDTRONIC 5311 PACING SYSTEM ANALYZER— 510(k) K850077

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K850077 for MEDTRONIC 5311 PACING SYSTEM ANALYZER, Substantially Equivalent on 1985-07-16. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DTC
Advisory panel: Cardiovascular
Date received: 1985-01-09
Decision date: 1985-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code DTC

product code DTC

Injury: 136
Malfunction: 3,400
Total: 3,536

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.