510(k) Report

FDA applicant

Pfm Produkte Fur Die Medizin AG

Trabuco Canyon, CA3 decisions2000–20021 recall

FDA records 3 decisions for Pfm Produkte Fur Die Medizin AG (Trabuco Canyon, CA) from 2000 to 2002: 3 510(k) clearances. Most are in product codes DXE (Catheter, Embolectomy) and FPA (Set, Administration, Intravascular). Its devices cite 2 predicates, 0 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 Pfm Produkte Fur Die Medizin AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pfm Produkte Fur Die Medizin AG since 2007.

Recalls per year

1in 2026

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pfm Produkte Fur Die Medizin AG 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?

  • DXECatheter, Embolectomy1decision
  • FPASet, Administration, Intravascular1decision
  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K002471Jetcan Huber Neeedle SetPfm Produkte Fur Die Medizin AG · 20001cites it

What has FDA decided for it lately?

  • K011783Multi-Snare SetPfm Produkte Fur Die Medizin AG · 20021 recall
  • K002471Jetcan Huber Neeedle SetPfm Produkte Fur Die Medizin AG · 2000
  • K001716Redon SetPfm Produkte Fur Die Medizin AG · 2000

All 3 as Pfm Produkte Fur Die Medizin AG →

What has been recalled?

1 recall linked to its devices; the latest:

  • K011783Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310Apr 21, 2026Class II