# Acrostak (Schweiz) AG · 89-08 · SWITZERLAND — FDA import alert red lists: firms subject to detention without physical examination

For Acrostak (Schweiz) AG · 89-08 · SWITZERLAND, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is SWITZERLAND; product is Percutaneous Catheter; M CATH FLEXY; product code is 74 D - - QY Catheter, Percutaneous; date published is 05/09/2024; address is Stegackerstrasse 14 , Winterthur, Zurich SWITZERLAND, verified against its source on 2026-09-16.

- **Firm:** Acrostak (Schweiz) AG _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** SWITZERLAND _(verified: appears in the quote below)_
- **Address:** Stegackerstrasse 14 , Winterthur, Zurich SWITZERLAND _(verified: appears in the quote below)_
- **Date published:** 05/09/2024 _(verified: appears in the quote below)_
- **Product code:** 74 D - - QY Catheter, Percutaneous _(verified: appears in the quote below)_
- **Product:** Percutaneous Catheter; M CATH FLEXY _(verified: appears in the quote below)_

## What the source says

> Acrostak (Schweiz) AG Date Published : 05/09/2024 Stegackerstrasse 14 , Winterthur, Zurich SWITZERLAND 74 D - - QY Catheter, Percutaneous Date Published: 05/09/2024 Desc: Percutaneous Catheter; M CATH FLEXY

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).