510(k) Report

FDA applicant

Angeion Corp.

Plymouth, MN7 decisions1987–19932 recalls

FDA records 7 decisions for Angeion Corp. (Plymouth, MN) from 1987 to 1993: 7 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and MAV (Syringe, Balloon Inflation). 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 Angeion Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Angeion Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Angeion 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?

  • DYBIntroducer, Catheter3decisions
  • MAVSyringe, Balloon Inflation1decision
  • DXTInjector And Syringe, Angiographic1decision
  • ODCEndoscope Channel Accessory1decision
  • GBXCatheter, Irrigation1decision

Who builds on its devices?

Later devices cite its devices 7 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.

  • K894446Angeion Hemostasis Valve IntroducerAngeion Corp. · 19893cite it
  • K895580Y-Adapter W/Thouy BorstAngeion Corp. · 19903cite it
  • K871153Catheter IntroducerAngeion Corp. · 19871cites it

What has FDA decided for it lately?

  • K921757Angeion Igital AngeflatorAngeion Corp. · 1993
  • K925533Angestat (R) Pericardial Drainage Sheath SetAngeion Corp. · 1993
  • K915719Angeion Endoscopic Valve SealAngeion Corp. · 1992
  • K902377Angeflator (TM)Angeion Corp. · 1990
  • K895580Y-Adapter W/Thouy BorstAngeion Corp. · 1990
  • K894446Angeion Hemostasis Valve IntroducerAngeion Corp. · 19891 recall
  • K871153Catheter IntroducerAngeion Corp. · 19872 recalls

All 7 as Angeion Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K871153Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 ***…Sep 13, 2005
  • K871152Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K…May 27, 2005