TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880— 510(k) K811318

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K811318 for TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880, Substantially Equivalent on 1981-07-20. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1981-05-12
Decision date: 1981-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.