510(k) K042105— CLIPPER DIAGNOSTIC ELECTRODE CATHETER

Substantially Equivalent

Bard Electrophysiology

Clearance details

Applicant: Bard Electrophysiology
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2004-08-04
Decision date: 2004-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Lowell, MA, US

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.