FDA.reportPublic FDA data

PolarCath

Primary DI
B479T50100135010
Brand
PolarCath
Company
Nucryo Vascular
Model
T5010013501
Device description
Peripheral dilation catheter, over the wire 6F (5.0mm x 100mm, 135cm)
Published
2018-03-19
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
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B479T50100135010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045796615
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B479NC30000010PolarCathNC30000012018-03-19
B479P4100120010PolarCathP4100120012018-03-19
B479P4150120010PolarCathP4150120012018-03-19
B479P440120010PolarCathP440120012018-03-19
B479P5100120010PolarCath P5100120012018-03-19
B479P5150120010PolarCathP5150120012018-03-19
B479P540120010PolarCathP540120012018-03-19
B479P6100120010PolarCath P6100120012018-03-19
B479P6150120010PolarCathP6150120012018-03-19
B479P640120010PolarCathP640120012018-03-19
B479P740120010PolarCathP740120012018-03-19
B479P840120010PolarCathP840120012018-03-19
B479PCE10000000PolarCathPCE10000002018-03-19
B479PCIU5000000CryoPlastyPCIU5000002018-03-19
B479T20100150010PolarCathT20100150012018-03-19
B479T20150150010PolarCathT20150150012018-03-19
B479T2040150010PolarCathT2040150012018-03-19
B479T25100150010PolarCathT25100150012018-03-19
B479T25150150010PolarCathT25150150012018-03-19
B479T2540150010PolarCathT2540150012018-03-19

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Primary DI, Brand, Company table
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