FDA.reportPublic FDA data

CenterCross Ultra LV Catheter

Primary DI
B094LV01000
Brand
CenterCross Ultra LV Catheter
Company
ROXWOOD MEDICAL, INC.
Model
LV-0100
Device description
The CenterCross Ultra LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
Published
2017-04-19
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

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B094LV01000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blunt-microdissection atherectomy catheterA manually-powered instrument intended to be used to create a pathway through an occluded blood vessel to facilitate the intraluminal placement of a conventional guidewire beyond a stenotic lesion [especially a chronic total occlusion (CTO) of a coronary artery], prior to further percutaneous intervention to remove the lesion. It typically consists of a long, thin, flexible segment, introduced into the vasculature, that is equipped to mechanically disrupt the lesion (e.g., by blunt microdissection) through manipulation of hand controls at the proximal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055819211
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B094CC01000CenterCross CatheterCC-01002016-04-27
B094CCX01000CenterCross Catheter, CECCX-01002017-08-09
B094MC01000MultiCross CatheterMC-01002016-04-27
B094MCX01000MultiCross Catheter, CEMCX-01002017-08-09
B094UC01000CenterCross Ultra CatheterUC-01002017-04-12
B094UCX01000CenterCross Ultra Catheter, CEUCX-01002017-08-09
00858480007008CenterCross CatheterCC-01002017-08-24
00858480007046MultiCross CatheterMC-01002017-08-24
00858480007053CenterCross Ultra CatheterUC-01002017-08-24
00858480007060CenterCross Ultra LV CatheterLV-01002017-08-30
00858480007077CenterCross Catheter,CECCX-01002018-04-19
00858480007084MultiCross Catheter, CEMCX-01002018-04-19
00858480007091CenterCross Ultra Catheter, CEUCX-01002018-04-19
00858480007015Micro14 MicroCross CatheterRC-00142017-08-24
00858480007022Micro18 MicroCross CatheterRC-00182017-08-24
00858480007039Micro14es MicroCross CatheterRC-10142017-08-24
00858480007107Micro14 MicroCross Catheter,CERCX-00142018-04-19
00858480007114Micro14es MicroCross Catheter, CERCX-10142018-04-19
00858480007121Micro18 MicroCross Catheter, CERCX-00182018-04-19
00858480007138MicroCross 14 Catheter, 135cmRC-20142018-09-20

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