HRSpheres Narrow-Size Embolic Microspheres
K-Number: K210562 · 2021-10-01
Decision Date2021-10-01
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
HRSpheres Narrow-Size Embolic Microspheres is a medical device manufactured by Suzhou Hengrui Hongyuan Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-10-01 under approval 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. It is manufactured by Suzhou Hengrui Hongyuan Medical Co., Ltd.. The 510(k) number is K210562.
When was HRSpheres Narrow-Size Embolic Microspheres approved by the FDA?
HRSpheres Narrow-Size Embolic Microspheres received FDA 510(k) clearance on 2021-10-01, under approval number K210562.
What company makes HRSpheres Narrow-Size Embolic Microspheres?
HRSpheres Narrow-Size Embolic Microspheres is manufactured by Suzhou Hengrui Hongyuan Medical Co., Ltd..
What is the FDA product code for HRSpheres Narrow-Size Embolic Microspheres?
The FDA product code for HRSpheres Narrow-Size Embolic Microspheres is 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.