510(k) Report

FDA applicant

Chestnut Medical Technologies, Inc.

Menlo Park, CA3 decisions2005–20101 recall

FDA records 3 decisions for Chestnut Medical Technologies, Inc. (Menlo Park, CA) from 2005 to 2010: 3 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and KRA (Catheter, Continuous Flush). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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 Chestnut Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1, 1 Class I
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • DQYCatheter, Percutaneous2decisions
  • KRACatheter, Continuous Flush1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K091559Marksmann CatheterChestnut Medical Technologies, Inc. · 20095cite it
  • K043580Alligator Retrieval Device (Ard)Chestnut Medical Technologies, Inc. · 20051cites it

What has FDA decided for it lately?

  • K093977Alligator-HD Retrieval Device (Ard-HD), Model FA-88840-XXChestnut Medical Technologies, Inc. · 2010
  • K091559Marksmann CatheterChestnut Medical Technologies, Inc. · 2009
  • K043580Alligator Retrieval Device (Ard)Chestnut Medical Technologies, Inc. · 20051 Class I recall

All 3 as Chestnut Medical Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K043580Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for…Apr 1, 2014Class I