K944957

Substantially Equivalent

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500

Applicant: Medtronic Blood Systems, Inc.
Product code: LDF
Advisory panel: Cardiovascular
Date received: 1994-10-07
Decision date: 1995-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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.