TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE— 510(k) K033858

Substantially Equivalent

European Custom Manufacturing BV

FDA 510(k) clearance K033858 for TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE, Substantially Equivalent on 2004-07-12. Applicant: European Custom Manufacturing BV.

Clearance details

Applicant: European Custom Manufacturing BV
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 2003-12-11
Decision date: 2004-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gemert, NL

Download summary PDF View on FDA.gov ↗

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.