510(k) Report

FDA applicant

Evalve, Inc.

Menlo Park, CA4 decisions2009–20100 recalls

FDA records 4 decisions for Evalve, Inc. (Menlo Park, CA) from 2009 to 2010: 4 510(k) clearances. All are in product code DRA (Catheter, Steerable). Its devices cite 11 predicates, 6 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, cardiovascular panel, where it files most

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

FDA decisions per year

2in 2010

2009: 22010: 2
2009high 2 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Evalve, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Evalve, 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?

  • DRACatheter, Steerable4decisions

Whose devices does it build on?

Its devices cite 11 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 6 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.

  • K083793Steerable Guide CatheterEvalve, Inc. · 20095cite it
  • K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 20094cite it
  • K093866Evalve Steerable Guide CatheterEvalve, Inc. · 20103cite it
  • K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 20103cite it

What has FDA decided for it lately?

  • K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010
  • K093866Evalve Steerable Guide CatheterEvalve, Inc. · 2010
  • K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009
  • K083793Steerable Guide CatheterEvalve, Inc. · 2009

All 4 as Evalve, Inc. →