510(k) Report

FDA applicant

Foxhollow Technologies, Inc.

Redwood City, CA2 decisions2006–20061 recall

FDA records 2 decisions for Foxhollow Technologies, Inc. (Redwood City, CA) in 2006: 2 510(k) clearances. All are in product code MCW (Catheter, Peripheral, Atherectomy). Its devices cite 2 predicates, 0 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 Foxhollow Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Foxhollow Technologies, Inc. since 2007.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Foxhollow Technologies, 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?

  • MCWCatheter, Peripheral, Atherectomy2decisions

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 10 times; 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.

  • K061188Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. · 20067cite it
  • K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300Foxhollow Technologies, Inc. · 20063cite it

What has FDA decided for it lately?

  • K061188Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. · 20061 recall
  • K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300Foxhollow Technologies, Inc. · 2006

All 2 as Foxhollow Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K061188SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550…Jan 21, 2010