510(k) Report

FDA applicant

Cardima, Inc.

Fremont, CA12 decisions1993–20062 recalls

FDA records 12 decisions for Cardima, Inc. (Fremont, CA) from 1993 to 2006: 12 510(k) clearances. Most are in product codes DRF (Catheter, Electrode Recording, Or Probe…) and DQY (Catheter, Percutaneous). Its devices cite 6 predicates, 2 of them its own earlier devices. 2 recalls are 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 Cardima, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardima, Inc. since 2007.

Recalls per year

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cardima, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DRFCatheter, Electrode Recording, Or Probe, Electrode Recording5decisions
  • DQYCatheter, Percutaneous3decisions
  • OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac…2decisions
  • KRACatheter, Continuous Flush1decision
  • DQXWire, Guide, Catheter1decision

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 2 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.

  • K974683Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 19996cite it
  • K973298Cardima Vueport Coronary Sinus Balloon Occlusion Guiding CatheterCardima, Inc. · 19985cite it
  • K022008Cardima Ablation SystemCardima, Inc. · 20032cite it
  • K970853Pathfinder 3MM Mapping Microcatheter (01-082001)Cardima, Inc. · 19971cites it
  • K955802PathfinderCardima, Inc. · 19971cites it

What has FDA decided for it lately?

  • K060715Modification to: Cardima Ablation SystemCardima, Inc. · 20062 recalls
  • K022008Cardima Ablation SystemCardima, Inc. · 20032 recalls
  • K974683Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
  • K972803Tracer O-T-W Mapping DeviceCardima, Inc. · 1999
  • K982835Electrode Switchbox, Model 11-081002Cardima, Inc. · 1998
  • K971975Cardima Pathfinder 1.5F Mapping MicrocatheterCardima, Inc. · 1998
  • K973298Cardima Vueport Coronary Sinus Balloon Occlusion Guiding CatheterCardima, Inc. · 1998
  • K970853Pathfinder 3MM Mapping Microcatheter (01-082001)Cardima, Inc. · 1997

All 12 as Cardima, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K022008Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device…May 20, 2010
  • K022008Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device…May 20, 2010