510(k) Report

FDA applicant

Coeur Medical

Washington, NC1 decision2003–20030 recalls

FDA records 1 decision for Coeur Medical (Washington, NC) in 2003: 1 510(k) clearance. All are in product code DXT (Injector And Syringe, Angiographic). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Coeur Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coeur Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Coeur Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXTInjector And Syringe, Angiographic1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K032920The Coeur Injector Adaptor/Pressure Jacket, Model C859-6003Coeur Medical · 20031cites it

What has FDA decided for it lately?

  • K032920The Coeur Injector Adaptor/Pressure Jacket, Model C859-6003Coeur Medical · 2003

The one decision as Coeur Medical →

Other applicant names beginning “Coeur”

FDA records each applicant name separately; these may or may not be the same firm.

Coeur, Inc. 14Coeur Laboratories, Inc. 10