Data / Medical devices / Switzerland / Straub Medical AG
Straub Medical AG: FDA-registered device maker in Wangs Sankt Gallen, Switzerland, 5 510(k) clearances
Straub Medical AG is registered with the FDA (registration 3008439199) in Wangs Sankt Gallen, Switzerland. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 30, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008439199
- Address
- Straubstrasse 12, Wangs Sankt Gallen, Switzerland, 7323
- Owner or operator
- Straub Medical AG (10061638)
- Roles
- Manufacturer
- First device listed
- November 18, 2019
- Registered through
- 2027
- Brand names listed
- Aspirex Thrombectomy System, Rotarex Atherectomy System, Rotarex S, Straub Endovascular System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Peripheral, Atherectomy | MCW | 2 | Manufacturer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 30, 2025 | K242757 | Rotarex Atherectomy System | MCW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| March 31, 2023 | K230356 | Aspirex Thrombectomy System | QEW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 21, 2022 | K220270 | Aspirex Thrombectomy System | QEW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 14, 2021 | K211738 | Rotarex Atherectomy System | MCW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 12, 2018 | K172315 | Straub Endovascular System | MCW | Substantially Equivalent | Straub Medical AG | accessdata.fda.gov |
Compare with other makers
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
- All makers of Wire, Guide, Catheter
- All makers of Catheter, Peripheral, Atherectomy
Updated January 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.