Data / Medical devices / Austria / Fresenius Kabi Austria GMBH
Fresenius Kabi Austria GMBH: FDA-registered device maker in GRAZ Steiermark, Austria, 1 510(k) clearance
Fresenius Kabi Austria GMBH is registered with the FDA (registration 3003708554) in GRAZ Steiermark, Austria. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003708554
- Address
- Hafnerstrasse 36, GRAZ Steiermark, Austria, A-8055
- Owner or operator
- FRESENIUS KABI DEUTSCHLAND GMBH (9097270)
- Roles
- Contract manufacturer, Contract sterilizer, Specification developer
- First device listed
- January 30, 2007
- Registered through
- 2026
- Brand names listed
- CATHETER, CORONARY, ATHERECTOMY, Catheter, peripheral, atherectomy, MSB- System and accessories, isolated heart, transport and preservation, Normothermic preservation system for transplantation of initially unacceptable donor lungsNormothermic machine perfusion, SET, PERFUSION, KIDNEY, DISPOSABLE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Coronary, Atherectomy | MCX | 3 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Catheter, Peripheral, Atherectomy | MCW | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation | QBA | 3 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | PHO | 3 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Set, Perfusion, Kidney, Disposable | KDL | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| System And Accessories, Isolated Heart, Transport And Preservation | MSB | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 29, 2021 | K211314 | OCS Lung Solution | MSB | Substantially Equivalent | TransMedics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Peripheral, Atherectomy
- All makers of Catheter, Coronary, Atherectomy
- All makers of Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
- All makers of Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
- All makers of System And Accessories, Isolated Heart, Transport And Preservation
- All makers of Set, Perfusion, Kidney, Disposable
Updated July 29, 2021. 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.