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HRSpheres Narrow-Size Embolic Microspheres

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210562

by Suzhou Hengrui Hongyuan Medical Co., Ltd.

Identifiers

510(k) Number
K210562 FDA 510(k)
FDA Product Code
KRD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3300 FDA 510(k)
Regulation Number
870.3300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

HRSpheres Narrow-Size Embolic Microspheres are a vascular device intended for promoting embolization. The device is classified as a Class II medical device under FDA regulation number 870.3300 and has been determined to be substantially equivalent to a predicate device through the traditional 510(k) pathway.

The device was cleared by the FDA on October 1, 2021 (K210562) and is manufactured by Suzhou Hengrui Hongyuan Medical Co., Ltd. in Suzhou, China. It is supplied as a non-sterile, single-use device for use in cardiovascular embolization procedures, with no MRI safety information provided in the data.

Frequently asked questions

What is the intended use of HRSpheres Narrow-Size Embolic Microspheres?

HRSpheres Narrow-Size Embolic Microspheres are intended for promoting embolization in vascular procedures, specifically within cardiovascular applications, as a Class II medical device designed to occlude blood flow in targeted vessels.

Is HRSpheres Narrow-Size Embolic Microspheres sterile or non-sterile, and is it reusable?

The device is supplied as a non-sterile, single-use product, meaning it must be sterilized by the user before use and is not intended for reuse after a single procedure to ensure patient safety and device integrity.

What regulatory pathway was used for HRSpheres Narrow-Size Embolic Microspheres, and when was it cleared?

HRSpheres Narrow-Size Embolic Microspheres received FDA clearance through the traditional 510(k) pathway on October 1, 2021, under K210562, demonstrating substantial equivalence to a predicate device in the same classification.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HRSpheres Narrow-Size Embolic Microspheres (K210562) — FDA 510 (k ..., EqualSpheres Narrow-size Embolic Microspheres-Suzhou Hengrui Medical ..., K210562 - HRSpheres Narrow-Size Embolic Microspheres | FDA 510(k), Products-Products-Suzhou Hengrui Medical Equipment Co., Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Suzhou Hengrui Hongyuan Medical Co., Ltd.

Sources (1)

  • FDA 510(k) K210562 24 fields · synced Oct 6, 2026