FDA.reportPublic FDA data

B-Rail 3.5F XL Delivery Catheter

Primary DI
M097BRX03460
Brand
B-Rail 3.5F XL Delivery Catheter
Company
BEST VASCULAR, INC.
Model
BRX-0346
Catalog number
BRX-0346
Device description
Beta-Rail 3.5F XL Delivery Catheter for use with the Novoste Beta-Cath System
Published
2015-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOUIntravascular Radiation Delivery System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOUIntravascular Radiation Delivery SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000018000
P000018040

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000018000BETA-CATH (TM) SYSTEMBest Vascular, Inc.2000-11-03MOU
P000018040BETA-CATH (TM) SYSTEMBest Vascular, Inc.2000-11-03MOU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M097BRX03460PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coronary artery brachytherapy system applicator, manual-afterloadingA sterile flexible tube intended to deliver/remove radiation therapy sources into a coronary artery, typically into the lumen of an implanted stent, as part of a manual-afterloading brachytherapy system. It is introduced into the patient and subsequently connected to the brachytherapy system source transfer device; it includes radiopaque markers to monitor the position of the radiation source. Disposable devices associated with the procedure may be included (e.g., syringe, connectors). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
770-717-0904xx@xx.xx

Regulatory Flags#

DUNS number
789032039
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M0975301770020Accessories Kit530177-002530177-0022015-09-10
M097ABR03460B-Rail 3.5F Delivery CatheterABR-0346ABR-03462015-09-10
M097MPK00021Medical Physicist KitMPK-0002MPK-00022015-09-10
M097PAP00350Procedure Accessory PackPAP-0035PAP-00352015-09-10
M097PAP00351Procedure Accessory Pack, 3.5F Coronary System, 5-PackPAP-0035PAP-00352016-06-22
M097RSK00020Novoste Response KitRSK-0002RSK-00022015-09-10
M097TDA20300Alpha VI 30mm Transfer DeviceTDA-2030TDA-20302015-09-10
M097TDA20400Alpha VI 40mm Transfer DeviceTDA-2040TDA-20402015-09-10
M097TDA20600Alpha VI 60mm Transfer DeviceTDA-2060TDA-20602015-09-10
M097TRC00020Twin Transport CaseTRC-0002TRC-00022015-09-10
M097TSC00010Temporary Storage ContainerTSC-0001TSC-00012015-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M097PAP00351Procedure Accessory Pack, 3.5F Coronary System, 5-PackBEST VASCULAR, INC.MOU2016-06-22
M0975301770020Accessories KitBEST VASCULAR, INC.MOU2015-09-10
M097ABR03460B-Rail 3.5F Delivery CatheterBEST VASCULAR, INC.MOU2015-09-10
M097MPK00021Medical Physicist KitBEST VASCULAR, INC.MOU2015-09-10
M097PAP00350Procedure Accessory PackBEST VASCULAR, INC.MOU2015-09-10
M097RSK00020Novoste Response KitBEST VASCULAR, INC.MOU2015-09-10
M097TDA20300Alpha VI 30mm Transfer DeviceBEST VASCULAR, INC.MOU2015-09-10
M097TDA20400Alpha VI 40mm Transfer DeviceBEST VASCULAR, INC.MOU2015-09-10
M097TDA20600Alpha VI 60mm Transfer DeviceBEST VASCULAR, INC.MOU2015-09-10
M097TRC00020Twin Transport CaseBEST VASCULAR, INC.MOU2015-09-10
M097TSC00010Temporary Storage ContainerBEST VASCULAR, INC.MOU2015-09-10