510(k) Report

FDA applicant

Invasatec

Eden Prairie, MN2 decisions1997–20004 recalls

FDA records 2 decisions for Invasatec (Eden Prairie, MN) from 1997 to 2000: 2 510(k) clearances. All are in product code DXT (Injector And Syringe, Angiographic). Its devices cite 4 predicates, 1 of them its own earlier devices. 4 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 Invasatec’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Invasatec since 2007.

Recalls per year

1in 2015

2007: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Invasatec 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?

  • DXTInjector And Syringe, Angiographic2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K963982Acist Angiographic InjectorInvasatec · 19973cite it
  • K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec · 20002cite it

What has FDA decided for it lately?

  • K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec · 20004 recalls
  • K963982Acist Angiographic InjectorInvasatec · 1997

All 2 as Invasatec →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K052744ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU…Dec 21, 2015Class II
  • K984231ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE…Oct 3, 2007
  • K984231AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management…May 19, 2004
  • K984231ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST…Oct 2, 2003