FDA.reportPublic FDA data

Paragon 8F Balloon Guide Cathete

Primary DI
06970908212079
Brand
Paragon 8F Balloon Guide Cathete
Company
Shanghai Wallaby Medical Technologies Co., Inc.
Model
BG8F085
Published
2026-04-15
Public version status
New
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
06970908212079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970908212079069709082120796970908212079

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.

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
06970908212086Paragon 8F Balloon Guide CatheteBG8F0952026-04-15
06970908212093Paragon 8F Balloon Guide CatheteBG8F0852024-10-11
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
06970908212840Avenir10CSW020202025-01-15
06970908212857Avenir10CSW030202025-01-15
06970908212864Avenir10CSW030302025-01-15
06970908212871Avenir10CSW040302025-01-15
06970908212888Avenir10CSW040402025-01-15
06970908212901Esperance 3+ Aspiration Catheter SystemASP3F133KIT2024-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623352AXS LiftStryker CorporationQJP2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327623390AXS LiftStryker CorporationQJP2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
00763000539351RebarMicro Therapeutics, Inc.QJP2022-02-27
07613327519372AXS VECTA 46Stryker CorporationQJP2021-12-17
07613327313956Trevo Trak 21Stryker CorporationQJP2020-04-17
00763000270346Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270353Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
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00763000270216Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
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00763000270292Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07