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Polyvinyl Alcohol Embolic Microspheres

by Canyon Medical Inc.

510(k) K250209

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250209 Date23 Sep 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KRD
FDA applicant
Canyon Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 870.3300
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Polyvinyl Alcohol Embolic Microspheres are synthetic embolic agents designed for vascular embolization procedures. These microspheres are used to occlude blood vessels, thereby interrupting blood flow to targeted tissues such as tumors, arteriovenous malformations, or other vascular anomalies. Their primary function is to promote embolization by physically blocking blood vessels, reducing perfusion to the intended area.

The device is supplied as a sterile, single-use product and is classified as a Class II medical device under FDA regulations. Available in calibrated sizes ranging from 75 to 1200 micrometers, these microspheres are intended for use in interventional radiology and cardiology settings. They are packaged for aseptic handling and comply with FDA 510(k) clearance requirements, ensuring regulatory adherence for clinical applications.

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