FDA.reportPublic FDA data

Gateway®

Primary DI
08714729791287
Brand
Gateway®
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0032072209400
Catalog number
M0032072209400
Device description
PTA Balloon Catheter
Published
2014-09-24
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
NJEintracranial neurovascular stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJEIntracranial Neurovascular StentUnknownf

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729791287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729791287087147297912878714729791287

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 cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00859030005260PulseRider Aneurysm Neck Reconstruction Device Connection CableMedos International SàrlNJE2019-09-17
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00810170014420LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014437LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014451LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014468LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170016288LVISMicrovention, Inc.NJE2018-11-25
00810170016295LVISMicrovention, Inc.NJE2018-11-25
00810170016301LVISMicrovention, Inc.NJE2018-11-25
00810170016318LVISMicrovention, Inc.NJE2018-11-25
00810170016325LVISMicrovention, Inc.NJE2018-11-25
00810170016332LVISMicrovention, Inc.NJE2018-11-25
00810170016349LVISMicrovention, Inc.NJE2018-11-25
00810170018510LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018527LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018619LVISMicrovention, Inc.NJE2018-11-25
00810170018626LVISMicrovention, Inc.NJE2018-11-25
00810170018961LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018978LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018985LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018992LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170019005LVISMicrovention, Inc.NJE2018-11-25
00810170019012LVISMicrovention, Inc.NJE2018-11-25
00810170019029LVISMicrovention, Inc.NJE2018-11-25
00810170019036LVISMicrovention, Inc.NJE2018-11-25