FDA applicant

Endocardial Solutions, Inc.

St. Paul, MN8 decisions1999–20040 recalls

FDA records 8 decisions for Endocardial Solutions, Inc. (St. Paul, MN) from 1999 to 2004: 8 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and MTD (Catheter, Intracardiac Mapping, High-Density…). Its devices cite 4 predicates, 4 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 Endocardial Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Endocardial Solutions, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Endocardial Solutions, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?