510(k) Report

FDA applicant

Xtrak Medical, Inc.

Hopkonton, MA3 decisions2002–20031 recall

FDA records 3 decisions for Xtrak Medical, Inc. (Hopkonton, MA) from 2002 to 2003: 3 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and MCW (Catheter, Peripheral, Atherectomy). Its devices cite 4 predicates, 1 of them its own earlier devices. 1 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 Xtrak Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Xtrak Medical, Inc. since 2007.

Recalls per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Xtrak Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xtrak Medical, Inc.’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?

  • DQYCatheter, Percutaneous1decision
  • MCWCatheter, Peripheral, Atherectomy1decision
  • QEWPeripheral Mechanical Thrombectomy With Aspiration1decision

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.

  • K032660Xtrak Support CatheterXtrak Medical, Inc. · 20031cites it
  • K013473XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model # CT0006001; XTD Collection…Xtrak Medical, Inc. · 20021cites it

What has FDA decided for it lately?

  • K032660Xtrak Support CatheterXtrak Medical, Inc. · 2003
  • K021641XTD Thrombectomy Catheter, XX CMXtrak Medical, Inc. · 20021 recall
  • K013473XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model # CT0006001; XTD Collection…Xtrak Medical, Inc. · 2002

All 3 as Xtrak Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K021641The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system…May 1, 2024Class II