FDA 510(k)

HRSpheres Narrow-Size Embolic Microspheres

K-Number: K210562 · 2021-10-01

ApplicantSuzhou Hengrui Hongyuan Medical Co., Ltd.

Decision Date2021-10-01

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HRSpheres Narrow-Size Embolic Microspheres is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Hengrui Hongyuan Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-10-01 under 510(k) number K210562. 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 HRSpheres Narrow-Size Embolic Microspheres?

HRSpheres Narrow-Size Embolic Microspheres is a medical device that received FDA 510(k) clearance on 2021-10-01. The listed applicant is Suzhou Hengrui Hongyuan Medical Co., Ltd.. The 510(k) number is K210562.

When did HRSpheres Narrow-Size Embolic Microspheres receive FDA 510(k) clearance?

HRSpheres Narrow-Size Embolic Microspheres received FDA 510(k) clearance on 2021-10-01, under 510(k) number K210562.

Who is the listed applicant for HRSpheres Narrow-Size Embolic Microspheres?

The FDA 510(k) record lists Suzhou Hengrui Hongyuan Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HRSpheres Narrow-Size Embolic Microspheres?

The FDA product code for HRSpheres Narrow-Size Embolic Microspheres is KRD.

Other records listing Suzhou Hengrui Hongyuan Medical Co., Ltd. as applicant

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Official Source

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