FDA.reportPublic FDA data

Easi-Vue embolic microspheres System

Primary DI
00850042341018
Brand
Easi-Vue embolic microspheres System
Company
ABK Biomedical Incorporated
Model
Administration Kit 50 micron
Catalog number
EVA50
Published
2022-10-24
Public version status
Update
Distribution status
Not 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
K220567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220567000Easi-Vue embolic microspheres SystemAbk Biomedical, Inc.2022-09-07KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850042341018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042341018008500423410188500423410180850042341018

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
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
00850042341087Easi-Vue embolic microspheres SystemEVD502024-03-12
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

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