510(k) Report

FDA applicant

Medtronic Cardiac Surgery, Medtronic, Inc.

Anaheim, CA2 decisions1996–19960 recalls

FDA records 2 decisions for Medtronic Cardiac Surgery, Medtronic, Inc. (Anaheim, CA) in 1996: 2 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and DTL (Adaptor, Stopcock, Manifold, Fitting…). Its devices cite 5 predicates, 0 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 Medtronic Cardiac Surgery, Medtronic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Cardiac Surgery, Medtronic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medtronic Cardiac Surgery, Medtronic…’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?

  • DQXWire, Guide, Catheter1decision
  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K960755Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 19963cite it
  • K953564Medtronic Overpressure/Vacuum Relief ValveMedtronic Cardiac Surgery, Medtronic, Inc. · 19961cites it

What has FDA decided for it lately?

  • K960755Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 1996
  • K953564Medtronic Overpressure/Vacuum Relief ValveMedtronic Cardiac Surgery, Medtronic, Inc. · 1996

All 2 as Medtronic Cardiac Surgery, Medtronic, Inc. →