FDA Registration
Active
🇩🇪 Germany
BeBack crossing catheter
Reg #: 3009128730
·
FEI: 3009128730
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BENTLEY INNOMED GMBH
- Registration Number
- 3009128730
- FEI Number
- 3009128730
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lotzenaecker 3
- City
- Hechingen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K211802
Owner / Operator
- Firm Name
- Bentley InnoMed GmbH
- Operator Number
- 10087691
- Address
- Lotzenaecker 3
- City
- Hechingen
- State
- Baden-Wurttemberg
- Postal Code
- 72379
- Country
- DE
US Agent
- Business Name
- Bentley Inc.
- Contact Name
- Kevin Temerowski
- Address
- 2220 Northmont Pkwy Ste 250
- City
- Duluth
- State
- GA
- ZIP
- 30096
- Country
- US
- [email protected]
- Phone
- 248 9106840
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2023-03-28 |
Proprietary Names
BeBack crossing catheter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility