K173871

Substantially Equivalent

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres

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

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.