FDA.reportPublic FDA data

EMBOGUARD

Primary DI
10886704082736
Brand
EMBOGUARD
Company
NEURAVI LIMITED
Model
BG8785U
Catalog number
BG8785U
Device description
EMBOGUARD Balloon Guide Catheter
Published
2021-12-22
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
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212340000
K233924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212340000EMBOGUARD Balloon Guide CatheterNeuravi Limited2021-12-17QJP
K233924000EMBOGUARD Balloon Guide CatheterNeuravi Limited2024-04-18QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704082736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670408273610886704082736

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA 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 malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985010416
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704082859EMBOTRAPET309645ET3096452021-08-05
10886704082866EMBOTRAP ET309522ET3095222020-07-16
10886704084570EMBOTRAPET309537ET3095372020-07-16
10886704081326EmbotrapET009533ET0095332018-05-24
10886704082743EMBOGUARDBG8795UBG8795U2021-12-22
10886704081319Embotrap ET009521ET0095212018-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04544050121057CELLO II Balloon Guide Catheter, 8F 90cmFUJI SYSTEMS CORPORATIONQJP2026-05-25
0086001552770787 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-05-18
0086001552771487 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-05-18
06970908212079Paragon 8F Balloon Guide CatheteShanghai Wallaby Medical Technologies Co., Inc.QJP2026-04-15
06970908212086Paragon 8F Balloon Guide CatheteShanghai Wallaby Medical Technologies Co., Inc.QJP2026-04-15
00850014025397APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025403APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025410APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025427APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
05391539370197Millipede 088 Access CatheterPERFUZE LIMITEDQJP2026-03-24
00810201980007SurfRider 13 MicrocatheterKANEKA AMERICAS HOLDING INCQJP2026-02-17
00810201980014SurfRider 13 MicrocatheterKANEKA AMERICAS HOLDING INCQJP2026-02-17
00850074235101Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-16
0086001030636987 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-02-02
0086001030637687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-02-02
00860013060619Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-02
00840303713128Carrier XL Delivery CatheterBALT USA LLCQJP2025-10-24
00840303713135Carrier XL Delivery CatheterBALT USA LLCQJP2025-10-24
00840303713470Carrier XL Delivery CatheterBALT USA LLCQJP2025-10-24
10886704088097CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088103CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088110CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088141CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704086437CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086451CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086475CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086499CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086512CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086536CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086550CEREGLIDECerenovus, Inc.QJP2025-09-26