CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
K-Number: K173871 · 2018-09-17
Decision Date2018-09-17
Product CodeNAJ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres is a medical device manufactured by Suzhou Hengrui Callisyn Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2018-09-17 under approval number K173871. The device is classified under product code NAJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres?
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres is a medical device that received FDA 510(k) clearance on 2018-09-17. It is manufactured by Suzhou Hengrui Callisyn Biomedical Co., Ltd.. The 510(k) number is K173871.
When was CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres approved by the FDA?
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres received FDA 510(k) clearance on 2018-09-17, under approval number K173871.
What company makes CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres?
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres is manufactured by Suzhou Hengrui Callisyn Biomedical Co., Ltd..
What is the FDA product code for CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres?
The FDA product code for CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres is NAJ.
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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.