Polyvinyl Alcohol Embolic Microspheres

GUDID 06954414670257

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.

Canyon Medical Inc.

Embolization particle, non-bioabsorbable

• Primary Device ID: 06954414670257
• NIH Device Record Key: 75ba25fb-b44b-4fdf-9e33-9c867b6e8d41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polyvinyl Alcohol Embolic Microspheres
• Version Model Number: PB-803
• Company DUNS: 527310648
• Company Name: Canyon Medical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06954414670257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250209

FDA Product Code

• KRD: Device, Vascular, For Promoting Embolization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-06
• Device Publish Date: 2026-02-26

On-Brand Devices [Polyvinyl Alcohol Embolic Microspheres]

• 06954414670462: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670455: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670448: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670431: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670424: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670417: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670400: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670394: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670387: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670370: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670363: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670356: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670349: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670332: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670325: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670318: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670301: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670295: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670288: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670271: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670264: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670257: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670240: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670233: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670226: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670219: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670202: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670196: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670189: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670172: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670165: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670158: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670141: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670134: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670127: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha
• 06954414670110: Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular sha