510(k) Report

FDA applicant

Infinity Extrusion & Engineering, Inc.

Santa Clara, CA1 decision2000–20000 recalls

FDA records 1 decision for Infinity Extrusion & Engineering, Inc. (Santa Clara, CA) in 2000: 1 510(k) clearance. All are in product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). 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 Infinity Extrusion & Engineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Infinity Extrusion & Engineering, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Infinity Extrusion & Engineering, 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?

  • LITCatheter, Angioplasty, Peripheral, Transluminal1decision

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.

  • K993913TRUEInfinity Extrusion & Engineering, Inc. · 20001cites it

What has FDA decided for it lately?

  • K993913TRUEInfinity Extrusion & Engineering, Inc. · 2000

The one decision as Infinity Extrusion & Engineering, Inc. →

Other applicant names beginning “Infinity”

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

Infinity Angioplasty Balloon Company, LLC 1Infinity Surgical Technology, Inc. 1