Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006513822

FEI Number

3006513822

Entity Name

Lutonix, Inc.

City/State/Country

Tempe, AZ, US

Establishment Address

1625 West 3rd Street, Tempe, AZ 85281, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

C. R. Bard, Inc. (Owner Number: 2212754)

Owner / Operator Contact Address

1 Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P130024

All Registered Proprietary Names

Lutonix 018 Drug Coated Balloon PTA Catheter Lutonix 035 Drug Coated Balloon PTA Catheter Lutonix Drug Coated Balloon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2014-10-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

C. R. Bard, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1725056	MEDIVANCE, INC.	LOUISVILLE, CO, US
1223089	DAVOL INC.	WOBURN, MA, US
3002504068	Bard European Distribution Center NV	Olen Antwerpen, BE
1213643	DAVOL INC., SUB. C.R. BARD, INC.	Warwick, RI, US
1424526	BARD BRACHYTHERAPY, INC	CAROL STREAM, IL, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006513822. Last updated year: 2026. Please use registration number 3006513822 when referencing this establishment in official correspondence.