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FDA 510(k)

Polyvinyl Alcohol Embolic Microspheres

K-Number: K250209 · 2025-09-23

ApplicantCanyon Medical, Inc.
Decision Date2025-09-23
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Polyvinyl Alcohol Embolic Microspheres is a medical device manufactured by Canyon Medical, Inc.. It received FDA 510(k) clearance on 2025-09-23 under approval number K250209. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polyvinyl Alcohol Embolic Microspheres?

Polyvinyl Alcohol Embolic Microspheres is a medical device that received FDA 510(k) clearance on 2025-09-23. It is manufactured by Canyon Medical, Inc.. The 510(k) number is K250209.

When was Polyvinyl Alcohol Embolic Microspheres approved by the FDA?

Polyvinyl Alcohol Embolic Microspheres received FDA 510(k) clearance on 2025-09-23, under approval number K250209.

What company makes Polyvinyl Alcohol Embolic Microspheres?

Polyvinyl Alcohol Embolic Microspheres is manufactured by Canyon Medical, Inc..

What is the FDA product code for Polyvinyl Alcohol Embolic Microspheres?

The FDA product code for Polyvinyl Alcohol Embolic Microspheres is KRD.

Related Clinical Trials

NCT05112926 Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40246727 [Discussion on Registration Evaluation Concerns of Embolic Microsphere Devices]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

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K222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle K241827Microwave Ablation Generator (KY-2000A, KY-2100A) K241825Microwave Ablation Antennas K233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle

Related Devices (Code: KRD)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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