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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 the device name listed in this FDA 510(k) record. The listed applicant is Canyon Medical, Inc.. It received FDA 510(k) clearance on 2025-09-23 under 510(k) 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. The listed applicant is Canyon Medical, Inc.. The 510(k) number is K250209.

When did Polyvinyl Alcohol Embolic Microspheres receive FDA 510(k) clearance?

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

Who is the listed applicant for Polyvinyl Alcohol Embolic Microspheres?

The FDA 510(k) record lists Canyon Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Canyon Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241827Microwave Ablation Generator (KY-2000A, KY-2100A)K241825Microwave Ablation AntennasK233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy NeedleK222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle

Related Devices (Code: KRD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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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