CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
K-Number: K173871 · 2018-09-17
Device Summary
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. The listed applicant is Suzhou Hengrui Callisyn Biomedical Co., Ltd.. The 510(k) number is K173871.
When did CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres receive FDA 510(k) clearance?
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres received FDA 510(k) clearance on 2018-09-17, under 510(k) number K173871.
Who is the listed applicant for CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres?
The FDA 510(k) record lists Suzhou Hengrui Callisyn Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
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.
Related Devices (Code: NAJ)
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.
Official Source
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