K831695

Substantially Equivalent

TEMP. CARDIAC PACING WIRE TME 60/61/65

Applicant: Oscor, Inc.
Product code: LDF
Advisory panel: Cardiovascular
Date received: 1983-05-25
Decision date: 1983-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harbor, FL, 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.