510(k) Report

FDA applicant

Cardiac Pathways Corp.

Sunnyvale, CA5 decisions1997–20001 recall

FDA records 5 decisions for Cardiac Pathways Corp. (Sunnyvale, CA) from 1997 to 2000: 5 510(k) clearances. Most are in product codes DRF (Catheter, Electrode Recording, Or Probe…) and MTD (Catheter, Intracardiac Mapping, High-Density…). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 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 Cardiac Pathways Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiac Pathways Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiac Pathways Corp. 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?

  • DRFCatheter, Electrode Recording, Or Probe, Electrode Recording3decisions
  • MTDCatheter, Intracardiac Mapping, High-Density Array2decisions

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K992912Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac Pathways Radii Catheter…Cardiac Pathways Corp. · 20002cite it
  • K982540Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial High Density Array…Cardiac Pathways Corp. · 19991cites it

What has FDA decided for it lately?

  • K992912Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac Pathways Radii Catheter…Cardiac Pathways Corp. · 20001 recall
  • K990795Mercator Atrial High Density Array Catheter; Cardiac Pathways Egm Adapter CablesCardiac Pathways Corp. · 1999
  • K982540Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial High Density Array…Cardiac Pathways Corp. · 1999
  • K983653Radii Diagnostic Electrophysiology Catheter, Model # 30411 B, C and DCardiac Pathways Corp. · 1998
  • K965066Arrhythmia Mapping System (8100/8300)Cardiac Pathways Corp. · 1997

All 5 as Cardiac Pathways Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K992912Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management…Mar 14, 2005