Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres
FDA 510(k) K133447 · Celonova Biosciences, Inc.
510(k) numberK133447
Submission
- Device name
- Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres
- Applicant
- Celonova Biosciences, Inc.
San Antonio, TX, US - Received
- November 12, 2013
- Decision date
- February 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NAJ – Agents, Embolic, For Treatment Of Uterine Fibroids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code NAJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233813 | Bearing nsPVA ExpressNAJ · Special | Merit Medical Systems, Inc. | 12/21/2023SE |
| K173871 | CalliSpheres Embolic Microspheres, 8Spheres Embolic MicrospheresNAJ · Traditional | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 09/17/2018SE |
| K130259 | Bearing Nspva Embolization ParticlesNAJ · Traditional | Merit Medical Systems, Inc. | 06/07/2013SE |
| K100663 | Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321NAJ · Traditional | Boston Scientific Corporation | 04/16/2010SE |
| K081768 | Cook Incorporated Polyvinyl Alcohol Foam Embolization ParticlesNAJ · Traditional | Cook Incorporated | 12/23/2008SE |
| K030966 | Contour Emboli Pva and FASTRACKER-325 Infusion CatheterNAJ · Traditional | Boston Scientific Corp | 09/23/2003SE |
| K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationNAJ · Traditional | Biosphere Medical, Inc. | 11/22/2002SE |
More from Biosphere Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141209 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…KRD · Traditional | 08/07/2014SE |
| K132675 | Embozene MicrospheresKRD · Special | 10/03/2013SE |
| K130307 | Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…KRD · Special | 03/04/2013SE |
| K073417 | Embozene MicrospheresKRD · Traditional | 12/15/2008SE |
Questions and answers
When was Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres cleared by the FDA?
Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres (K133447) received a 510(k) decision of Substantially Equivalent on February 24, 2014, 104 days after the submission was received.
What is the product code of K133447?
The FDA product code is NAJ – Agents, Embolic, For Treatment Of Uterine Fibroids, a Class II (moderate risk) device regulated under 21 CFR 870.3300.