CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres— 510(k) K173871
Substantially EquivalentSuzhou 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.. Device class: 2.
Clearance details
- Applicant
- Suzhou Hengrui Callisyn Biomedical Co., Ltd.
- Product code
- Code NAJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code NAJ
view all- K233813 — Bearing nsPVA Express
- K133447 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
- K130259 — BEARING NSPVA EMBOLIZATION PARTICLES
- K100663 — CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
- K081768 — COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
Adverse events under product code NAJ
product code NAJ- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . 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.