510(k) Report

FDA applicant

Gardia Medical, Ltd.

Caesarea, IL2 decisions2015–20180 recalls

FDA records 2 decisions for Gardia Medical, Ltd. (Caesarea, IL) from 2015 to 2018: 2 510(k) clearances. All are in product code NTE (Temporary Carotid Catheter For Embolic Capture). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Gardia 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 Gardia Medical, Ltd.’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 — Gardia Medical, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • NTETemporary Carotid Catheter For Embolic Capture2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K180023WirionGardia Medical, Ltd. · 20181cites it
  • K143570WirionGardia Medical · 20151cites it

What has FDA decided for it lately?

  • K180023WirionGardia Medical, Ltd. · 2018
  • K143570WirionGardia Medical · 2015

The one decision as Gardia Medical, Ltd. →The one decision as Gardia Medical →