510(k) Report

FDA applicant

Cardiovascular Innovations

Dallas, TX1 decision1998–19982 recalls

FDA records 1 decision for Cardiovascular Innovations (Dallas, TX) in 1998: 1 510(k) clearance. All are in product code DXT (Injector And Syringe, Angiographic). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are 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 Cardiovascular Innovations’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiovascular Innovations since 2007.

Recalls per year

1in 2021

2007: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Cardiovascular Innovations 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

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K973334OZ Power SyringeCardiovascular Innovations · 19981cites it

What has FDA decided for it lately?

  • K973334OZ Power SyringeCardiovascular Innovations · 19982 recalls

The one decision as Cardiovascular Innovations →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K973334LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product…Apr 6, 2021Class II
  • K973334CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic…Jul 18, 2007

Other applicant names beginning “Cardiovascular”

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

Cardiovascular Systems, Inc. 29Cardiovascular Imaging Systems, Inc. 19Cardiovascular Diagnostics, Inc. 13Cardiovascular Dynamics, Inc. 11Cardiovascular Devices, Inc. 8Cardiovascular Diagnostic Services 8Cardiovascular Imaging Technologies 7Cardiovascular Research, Inc. 2Cardiovascular Imaging Solutions, Ltd. 1Cardiovascular Group, Inc. 1Cardiovascular System, Inc. 1