FDA.reportPublic FDA data

Easi-Vue embolic microspheres System

Primary DI
00850042341087
Brand
Easi-Vue embolic microspheres System
Company
ABK Biomedical Incorporated
Model
EVD50
Published
2024-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234123000Easi-Vue® embolic microspheres SystemAbk Biomedical, Inc.2024-02-13KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850042341084PackageGS13In Commercial Distribution
00850042341087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004234108410850042341084
00850042341087008500423410878500423410870850042341087

GMDN Terms#

Term, Definition table
TermDefinition
Embolization particle, non-bioabsorbableA non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature16 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203463617
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042341018Easi-Vue embolic microspheres SystemAdministration Kit 50 micronEVA502022-10-24
00850042341025Easi-Vue embolic microspheres SystemAdministration Kit 100 micronEVA1002022-10-24
00850042341032Easi-Vue embolic microspheres SystemAdministration Kit 150 micronEVA1502022-10-24
00850042341094Easi-Vue embolic microspheres SystemEVD1002024-03-12
00850042341100Easi-Vue embolic microspheres SystemEVD1502024-03-12
10850042341091Easi-Vue embolic microspheres SystemEVD1002024-03-12
10850042341107Easi-Vue embolic microspheres SystemEVD1502024-03-12
00850042341049Easi-Vue embolic microspheres SystemRefill Syringe 50 micronEVR502022-10-24
00850042341056Easi-Vue embolic microspheres SystemRefill Syringe 100 micronEVR1002022-10-24
00850042341063Easi-Vue embolic microspheres SystemRefill Syringe 150 micronEVR1502022-10-24
10850042341046Easi-Vue embolic microspheres SystemRefill Syringe 50 micronEVR502022-10-24
10850042341053Easi-Vue embolic microspheres SystemRefill Syringe 100 micronEVR1002022-10-24
10850042341060Easi-Vue embolic microspheres SystemRefill Syringe 150 micronEVR1502022-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840303712053Prestige Coil SystemBALT USA LLCKRD2026-07-14
00840303712077Prestige Coil SystemBALT USA LLCKRD2026-07-14
00840303712091Prestige Coil SystemBALT USA LLCKRD2026-07-14
00840303712107Prestige Coil SystemBALT USA LLCKRD2026-07-14
06958698053355Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053362Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053379Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053386Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053393Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053409Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053416Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053423Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053430Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053447Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053454Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053461Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053478Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053485Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053492Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053508Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
07613327635096InZone ISTStryker CorporationKRD2026-07-08
00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06