510(k) Report

FDA applicant

Elective Vascular Intervention Inc. (Evi)

Walnut Creek, CA1 decision1997–19970 recalls

FDA records 1 decision for Elective Vascular Intervention Inc. (Evi) (Walnut Creek, CA) in 1997: 1 510(k) clearance. All are in product code FZP (Clip, Implantable). 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, general and plastic surgery panel, where it files most

How often FDA has decided Elective Vascular Intervention Inc. (Evi)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Elective Vascular Intervention Inc. (Evi) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Elective Vascular Intervention Inc. (Evi) 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?

  • FZPClip, Implantable1decision

Who builds on its devices?

Later devices cite its devices 9 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.

  • K971588Evi Sutured-Clip ApplierElective Vascular Intervention Inc. (Evi) · 19979cite it

What has FDA decided for it lately?

  • K971588Evi Sutured-Clip ApplierElective Vascular Intervention Inc. (Evi) · 1997

The one decision as Elective Vascular Intervention Inc. (Evi) →