510(k) Report

FDA applicant

Fox Hollow Technologies

Redwood City, CA5 decisions2003–20081 recall

FDA records 5 decisions for Fox Hollow Technologies (Redwood City, CA) from 2003 to 2008: 5 510(k) clearances. Most are in product codes MCW (Catheter, Peripheral, Atherectomy) and QEZ (Aspiration Thrombectomy Catheter). Its devices cite 8 predicates, 2 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 Fox Hollow Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fox Hollow Technologies’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, Atherectomy4decisions
  • QEZAspiration Thrombectomy Catheter1decision

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 2 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.

  • K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406…Fox Hollow Technologies · 20064cite it
  • K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300Fox Hollow Technologies · 20054cite it
  • K024243Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406Fox Hollow Technologies · 20034cite it

What has FDA decided for it lately?

  • K071432Silverhawk-R Peripheral Plaque Excision System for Surgical UseFox Hollow Technologies · 2008
  • K071826The Rinspirator, Models FG09770, FG08776, FG08777, FG08910Fox Hollow Technologies · 2007
  • K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406…Fox Hollow Technologies · 2006
  • K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300Fox Hollow Technologies · 2005
  • K024243Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406Fox Hollow Technologies · 20031 recall

All 5 as Fox Hollow Technologies →

What has been recalled?

1 recall linked to its devices; the latest:

  • K024243ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015…Jun 17, 2004