Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1424526

FEI Number

3002942387

Entity Name

BARD BRACHYTHERAPY, INC

City/State/Country

CAROL STREAM, IL, US

Establishment Address

295 E. LIES RD., CAROL STREAM, IL 60188, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,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

N/A

All Registered Proprietary Names

BrachySource Seed Implants QuickLink Delivery System ReadyLink Delivery System Palladium-103 Seed Implant Kits QuickLink Delivery System ReadyLink Delivery System Seedlinks SourceLink Connectors SourceLink Spacers BrachyStar Brachytherapy Needles brachytherapy seed implant needles BrachyStar Needles QuickLink Loader QuickLink Relay System SourceLink Loader

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2010-01-05
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2008-03-28
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2008-03-28
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	1999-12-16

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
3006513822	Lutonix, Inc.	Tempe, AZ, 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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973037	Avid N.I.T., Inc.	N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000	1998-01-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2012	Worldwide Medical Technologies, LLC	1	Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate

Similar Registrations

Registration Number	Establishment Name	Location
9617477	ECKERT & ZIEGLER BEBIG GMBH	BERLIN, DE
1226007	QSA-GLOBAL INC.	BURLINGTON, MA, US
1120804	BEST MEDICAL INTERNATIONAL, INC.	SPRINGFIELD, VA, US
3014663932	GT MEDICAL TECHNOLOGIES, INC	Tempe, AZ, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1424526. Last updated year: 2026. Please use registration number 1424526 when referencing this establishment in official correspondence.