FDA.reportPublic FDA data

Polyvinyl Alcohol Embolic Microspheres

Primary DI
06954414670141
Brand
Polyvinyl Alcohol Embolic Microspheres
Company
Canyon Medical Inc.
Model
PB-201
Device description
Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular shape, smooth surface, and calibrated size, which are formed as a result of chemical modification on polyvinyl alcohol (PVA) materials.
Published
2026-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K250209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250209000Polyvinyl Alcohol Embolic MicrospheresCanyon Medical, Inc.2025-09-23KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954414670141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954414670141069544146701416954414670141

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527310648
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
06954414670110Polyvinyl Alcohol Embolic MicrospheresPB-1012026-02-26
06954414670127Polyvinyl Alcohol Embolic MicrospheresPB-1022026-02-26
06954414670134Polyvinyl Alcohol Embolic MicrospheresPB-1032026-02-26
06954414670158Polyvinyl Alcohol Embolic MicrospheresPB-2022026-02-26
06954414670165Polyvinyl Alcohol Embolic MicrospheresPB-2032026-02-26
06954414670172Polyvinyl Alcohol Embolic MicrospheresPB-4012026-02-26
06954414670189Polyvinyl Alcohol Embolic MicrospheresPB-4022026-02-26
06954414670196Polyvinyl Alcohol Embolic MicrospheresPB-4032026-02-26
06954414670202Polyvinyl Alcohol Embolic MicrospheresPB-6012026-02-26
06954414670219Polyvinyl Alcohol Embolic MicrospheresPB-6022026-02-26
06954414670226Polyvinyl Alcohol Embolic MicrospheresPB-6032026-02-26
06954414670233Polyvinyl Alcohol Embolic MicrospheresPB-8012026-02-26
06954414670240Polyvinyl Alcohol Embolic MicrospheresPB-8022026-02-26
06954414670257Polyvinyl Alcohol Embolic MicrospheresPB-8032026-02-26
06954414670264Polyvinyl Alcohol Embolic MicrospheresPB-10512026-02-26
06954414670271Polyvinyl Alcohol Embolic MicrospheresPB-10522026-02-26
06954414670288Polyvinyl Alcohol Embolic MicrospheresPB-10532026-02-26
06954414670295Polyvinyl Alcohol Embolic MicrospheresPW-1012026-02-26
06954414670301Polyvinyl Alcohol Embolic MicrospheresPW-1022026-02-26
06954414670318Polyvinyl Alcohol Embolic MicrospheresPW-1032026-02-26

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