THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003— 510(k) K032920

Substantially Equivalent

Coeur Medical

FDA 510(k) clearance K032920 for THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003, Substantially Equivalent on 2003-12-16. Applicant: Coeur Medical.

Clearance details

Applicant: Coeur Medical
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2003-09-22
Decision date: 2003-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.