510(k) Report

FDA applicant

Creganna-Tactx Medical

Galway, IE2 decisions2011–20143 recalls

FDA records 2 decisions for Creganna-Tactx Medical (Galway, IE) from 2011 to 2014: 2 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and LOX (Catheters, Transluminal Coronary Angioplasty…). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 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 Creganna-Tactx Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12014: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2014

2013: 12014: 2
2011high 2 (2014) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Creganna-Tactx Medical by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DYBIntroducer, Catheter1decision
  • LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 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.

  • K110133Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation CatheterCreganna-Tactx Medical · 20115cite it
  • K140338Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)Creganna-Tactx Medical · 20141cites it

What has FDA decided for it lately?

  • K140338Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)Creganna-Tactx Medical · 2014
  • K110133Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation CatheterCreganna-Tactx Medical · 20113 recalls

All 2 as Creganna-Tactx Medical →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K110133Cordis EMPIRA NC RX PTCA Dilatation CatheterJun 23, 2014Class II
  • K110133Cordis EMPIRA RX PTCA Dilatation CatheterJun 23, 2014Class II
  • K110133Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.Feb 5, 2013Class II

Other applicant names beginning “Creganna-Tactx”

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

Creganna Medical Aslo Business AS Cregganna Tactx… 2Creganna Medical Also Doing Business AS Ceganna Tactx… 1Creganna Medical Devices 1