FDA.reportPublic FDA data

Paragon 8F Balloon Guide Cathete

Primary DI
06970908212093
Brand
Paragon 8F Balloon Guide Cathete
Company
Shanghai Wallaby Medical Technologies Co., Inc.
Model
BG8F085
Device description
V01
Published
2024-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970908212093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970908212093069709082120936970908212093

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544535295
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970908211171EsperanceDAC6F1312024-03-21
06970908211188EsperanceDAC6F1252024-03-21
06970908211195EsperanceDAC6F1152024-03-21
06970908211911EsperanceDAC5F1312024-03-21
06970908211928EsperanceDAC5F1252024-03-21
06970908211935EsperanceDAC5F1152024-03-21
06970908212079Paragon 8F Balloon Guide CatheteBG8F0852026-04-15
06970908212086Paragon 8F Balloon Guide CatheteBG8F0952026-04-15
06970908212109Paragon 8F Balloon Guide CatheteBG8F0952024-10-11
06970908212734Avenir10HSW010082025-01-15
06970908212741Avenir10HSW010102025-01-15
06970908212758Avenir10HSW015102025-01-15
06970908212765Avenir10HSW015152025-01-15
06970908212772Avenir10HSW020122025-01-15
06970908212789Avenir10HSW020202025-01-15
06970908212796Avenir10CSW010082025-01-15
06970908212802Avenir10CSW010102025-01-15
06970908212819Avenir10CSW015102025-01-15
06970908212826Avenir10CSW015152025-01-15
06970908212833Avenir10CSW020122025-01-15

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Primary DI, Brand, Company table
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00199150070145NAMEDTRONIC, INC.DQY2026-04-13
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
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00389701012896R2P NAVICROSSTERUMO MEDICAL CORPORATIONDQY2024-01-11
00389701012902R2P NAVICROSSTERUMO MEDICAL CORPORATIONDQY2024-01-11
10801902215502ARROWTELEFLEX INCORPORATEDDQY2023-07-10
10801902215267ARROWTELEFLEX INCORPORATEDDQY2023-07-07