Data / Medical devices / Germany / Bentley Innomed GMBH
Bentley Innomed GMBH: FDA-registered device maker in Hechingen Baden-Wurttemberg, Germany, 1 510(k) clearance
Bentley Innomed GMBH is registered with the FDA (registration 3009128730) in Hechingen Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 1, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009128730
- Address
- Lotzenaecker 3, Hechingen Baden-Wurttemberg, Germany, 72379
- Owner or operator
- Bentley InnoMed GmbH (10087691)
- Roles
- Specification developer
- First device listed
- March 28, 2023
- Registered through
- 2027
- Brand names listed
- BeBack crossing catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter For Crossing Total Occlusions | PDU | 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 |
|---|---|---|---|---|---|---|
| March 1, 2022 | K211802 | GoBack Crossing Catheter | PDU | Substantially Equivalent | Upstream Peripheral Technologies, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 1, 2022. 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.