510(k) Report

FDA applicant

Straub Medical AG

Wangs, CH1 decision2018–20181 recall

FDA records 1 decision for Straub Medical AG (Wangs, CH) in 2018: 1 510(k) clearance. All are in product code MCW (Catheter, Peripheral, Atherectomy). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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 Straub Medical AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1, 1 Class I
2018high 1 (2025) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Straub Medical AG by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MCWCatheter, Peripheral, Atherectomy1decision

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.

  • K172315Straub Endovascular SystemStraub Medical AG · 20181cites it

What has FDA decided for it lately?

  • K172315Straub Endovascular SystemStraub Medical AG · 20181 Class I recall

The one decision as Straub Medical AG →

What has been recalled?

1 recall linked to its devices; the latest:

  • K172315Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm…Feb 5, 2025Class I

Other applicant names beginning “Straub”

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

Straub Clinic and Hospital 2