UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493— 510(k) K922269

Substantially Equivalent

The Heart Valve Div. Medtronic Cardiovascular Surg

FDA 510(k) clearance K922269 for UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493, Substantially Equivalent on 1992-11-23. Applicant: The Heart Valve Div. Medtronic Cardiovascular Surg.

Clearance details

Applicant: The Heart Valve Div. Medtronic Cardiovascular Surg
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1992-05-14
Decision date: 1992-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.