510(k) Report

FDA applicant

Cruzar Medsystems, Inc.

Braintree, MA2 decisions2015–20220 recalls

FDA records 2 decisions for Cruzar Medsystems, Inc. (Braintree, MA) from 2015 to 2022: 2 510(k) clearances. All are in product code DQY (Catheter, Percutaneous). 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 Cruzar Medsystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2015: 12022: 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 — Cruzar Medsystems, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cruzar Medsystems, Inc.’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?

  • DQYCatheter, Percutaneous2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K151896Houdini CatheterCruzar Medsystems, Inc. · 20151cites it

What has FDA decided for it lately?

  • K213466Houdini Cross Support CatheterCruzar Medsystems, Inc. · 2022
  • K151896Houdini CatheterCruzar Medsystems, Inc. · 2015

All 2 as Cruzar Medsystems, Inc. →