510(k) Report

FDA applicant

Cardiogard Medical, Ltd.

Amherst, MA2 decisions2015–20190 recalls

FDA records 2 decisions for Cardiogard Medical, Ltd. (Amherst, MA) from 2015 to 2019: 2 510(k) clearances. All are in product code DWF (Catheter, Cannula And Tubing, Vascular…). Its devices cite 6 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 Cardiogard Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2015: 12019: 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 — Cardiogard Medical, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardiogard Medical, Ltd.’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?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions

Whose devices does it build on?

Its devices cite 6 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.

  • K141465Cardiogard Emboli Protection CannulaCardiogard Medical, Ltd. · 20151cites it

What has FDA decided for it lately?

  • K182302CardioGard Emboli Protection CannulaCardiogard Medical, Ltd. · 2019
  • K141465Cardiogard Emboli Protection CannulaCardiogard Medical, Ltd. · 2015

All 2 as Cardiogard Medical, Ltd. →