BENTLEY INNOMED GMBH

FDA Device Registration & Listing · Hechingen Baden-Wurttemberg, DE · Registration 3009128730

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009128730
FEI Number
3009128730
Entity Name
BENTLEY INNOMED GMBH
City/State/Country
Hechingen Baden-Wurttemberg, DE
Establishment Address
Lotzenaecker 3, Hechingen Baden-Wurttemberg 72379, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Bentley InnoMed GmbH (Owner Number: 10087691)
Owner / Operator Contact Address
Lotzenaecker 3, Hechingen, DE-BW 72379, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K211802
PMA Number
N/A

All Registered Proprietary Names

BeBack crossing catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2023-03-28

Official Correspondent

No official correspondent registered.

US Agent Details

Ben St Jean Business: Bentley USA Inc. Email: B.StJean@bentley.global Phone: (603) 2055772

Related Public Records

Same Entity

Bentley InnoMed GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071227 Spectranetics Corp. CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 2007-07-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009128730. Last updated year: 2026. Please use registration number 3009128730 when referencing this establishment in official correspondence.
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