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
Phone
248 9106840

Products

Device Name Product Code
Catheter For Crossing Total Occlusions PDU

Proprietary Names

BeBack crossing catheter

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility