COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)— 510(k) K965214

Name: FDA 510(k) clearance K965214
Creator: U.S. Food and Drug Administration
Published: 1997-03-28

Substantially Equivalent

Coeur Laboratories, Inc.

FDA 510(k) clearance K965214 for COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002), Substantially Equivalent on 1997-03-28. Applicant: Coeur Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Coeur Laboratories, Inc.
Product code: Code DTX
Device class: Class 2
Regulation: 21 CFR 870.4300
Advisory panel: Cardiovascular
Date received: 1996-12-30
Decision date: 1997-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTX

product code DTX

Death: 3
Malfunction: 497
Total: 500

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.