510(k) Report

FDA applicant

Marblehead Medical, LLC

Rochester Mn, MN2 decisions2020–20210 recalls

FDA records 2 decisions for Marblehead Medical, LLC (Rochester Mn, MN) from 2020 to 2021: 2 510(k) clearances. All are in product code QJP (Catheter, Percutaneous, Neurovasculature). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Marblehead Medical”.

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 Marblehead Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 12021: 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Marblehead Medical, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Marblehead Medical, LLC’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?

  • QJPCatheter, Percutaneous, Neurovasculature2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K200910BOSS Balloon Guide CatheterMarblehead Medical · 20201cites it

What has FDA decided for it lately?

  • K203840BOSS 8F Balloon Guide CatheterMarblehead Medical, LLC · 2021
  • K200910BOSS Balloon Guide CatheterMarblehead Medical · 2020

The one decision as Marblehead Medical, LLC →The one decision as Marblehead Medical →