510(k) Report

FDA applicant

The Catheter Exchange, Inc.

Encino, CA1 decision2005–20050 recalls

FDA records 1 decision for The Catheter Exchange, Inc. (Encino, CA) in 2005: 1 510(k) clearance. All are in product code GBX (Catheter, Irrigation). Its devices cite 2 predicates, 0 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for The Catheter Exchange, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like The Catheter Exchange, 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?

  • GBXCatheter, Irrigation1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K052286Deutsch Anti-Blockage Wound DrainThe Catheter Exchange, Inc. · 20051cites it

What has FDA decided for it lately?

  • K052286Deutsch Anti-Blockage Wound DrainThe Catheter Exchange, Inc. · 2005

The one decision as The Catheter Exchange, Inc. →

Other applicant names beginning “The”

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

Catheter Technology Corp. 13Catheter Innovations, Inc. 8Catheter Research, Inc. 8Catheter Research C/O Burditt, Bowles & Radzius 8Catheter Connections, Inc. 7Catheter Robotics, Inc. 3Catheter Precision, Inc. 2Catheter Sciences Co. 2Catheter, LLC 1Catheter Corp. of America 1