510(k) Report

FDA applicant

Medtronic Core Valve, LLC

Santa Rosa, CA2 decisions2015–20180 recalls

FDA records 2 decisions for Medtronic Core Valve, LLC (Santa Rosa, CA) from 2015 to 2018: 2 510(k) clearances. All are in product code DQX (Wire, Guide, Catheter). Its devices cite 2 predicates, 1 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 Core Valve, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2015: 12018: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Medtronic Core Valve, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQXWire, Guide, Catheter2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K181001Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 20182cite it
  • K150465Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 20151cites it

What has FDA decided for it lately?

  • K181001Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018
  • K150465Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015

All 2 as Medtronic Core Valve, LLC →