510(k) Report

FDA applicant

Alva Medical, Inc.

Mchenry, IL2 decisions1980–19800 recalls

FDA records 2 decisions for Alva Medical, Inc. (Mchenry, IL) in 1980: 2 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DRE (Dilator, Vessel, For Percutaneous…). 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 Alva Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alva Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Alva Medical, 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?

  • DYBIntroducer, Catheter1decision
  • DREDilator, Vessel, For Percutaneous Catheterization1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K801113Dilator, Vessel, for Perc. Catheter.Alva Medical, Inc. · 19801cites it

What has FDA decided for it lately?

  • K801113Dilator, Vessel, for Perc. Catheter.Alva Medical, Inc. · 1980
  • K800580Percutaneous Catheter IntroducerAlva Medical, Inc. · 1980

All 2 as Alva Medical, Inc. →

Other applicant names beginning “Alva”

FDA records each applicant name separately; these may or may not be the same firm.

Alva-Tech, Inc. 1