510(k) Report

FDA applicant

Cardiovention, Inc.

Santa Clara, CA4 decisions2002–20030 recalls

FDA records 4 decisions for Cardiovention, Inc. (Santa Clara, CA) from 2002 to 2003: 4 510(k) clearances. Most are in product codes DTQ (Console, Heart-Lung Machine, Cardiopulmonary…) and DTR (Heat-Exchanger, Cardiopulmonary Bypass). Its devices cite 5 predicates, 2 of them its own earlier devices. 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 Cardiovention, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiovention, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cardiovention, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass2decisions
  • DTRHeat-Exchanger, Cardiopulmonary Bypass1decision
  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K012325Cardiovention Corx System, Model FG 0001Cardiovention, Inc. · 20022cite it
  • K021694Cardiovention Powerbase Console, Model PBC-100Cardiovention, Inc. · 20031cites it

What has FDA decided for it lately?

  • K032068Cardiovention Corx Ios-200 System, Model Ios-200Cardiovention, Inc. · 2003
  • K030141Modification to Cardiovention Powerbase Console, Model PCB-100Cardiovention, Inc. · 2003
  • K021694Cardiovention Powerbase Console, Model PBC-100Cardiovention, Inc. · 2003
  • K012325Cardiovention Corx System, Model FG 0001Cardiovention, Inc. · 2002

All 4 as Cardiovention, Inc. →