CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres— 510(k) K173871

Substantially Equivalent

Suzhou Hengrui Callisyn Biomedical Co., Ltd.

FDA 510(k) clearance K173871 for CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres, Substantially Equivalent on 2018-09-17. Applicant: Suzhou Hengrui Callisyn Biomedical Co., Ltd..

Clearance details

Applicant: Suzhou Hengrui Callisyn Biomedical Co., Ltd.
Product code: Code NAJ
Advisory panel: Cardiovascular
Date received: 2017-12-20
Decision date: 2018-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code NAJ

product code NAJ

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.