EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES— 510(k) K133447
Substantially EquivalentCelonova Biosciences, Inc.
FDA 510(k) clearance K133447 for EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, Substantially Equivalent on 2014-02-24. Applicant: Celonova Biosciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Celonova Biosciences, Inc.
- 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
- San Antonio, TX, US
Recent devices under product code NAJ
view all- K233813 — Bearing nsPVA Express
- K173871 — CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
- K130259 — BEARING NSPVA EMBOLIZATION PARTICLES
- K100663 — CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
- K081768 — COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
More clearances from Celonova Biosciences, Inc.
view all- K141209 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES
- K132675 — EMBOZENE MICROSPHERES
- K130307 — ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE
- K073417 — EMBOZENE MICROSPHERES
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.