510(k) Report

FDA applicant

Heartware, Inc.

North Attleboro, MA1 decision1997–19970 recalls

FDA records 1 decision for Heartware, Inc. (North Attleboro, MA) in 1997: 1 510(k) clearance. All are in product code IZI (System, X-Ray, Angiographic). Its devices cite 2 predicates, 0 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, radiology panel, where it files most

How often FDA has decided Heartware, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heartware, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Heartware, 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?

  • IZISystem, X-Ray, Angiographic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K972229Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 19971cites it

What has FDA decided for it lately?

  • K972229Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997

The one decision as Heartware, Inc. →

Other applicant names beginning “Heartware”

FDA records each applicant name separately; these may or may not be the same firm.

Heartware Intl. Corp. 4