Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Oncozene Microspheres
FDA 510(k) K141209 · Celonova Biosciences, Inc.
510(k) numberK141209
Submission
- Device name
- Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Oncozene Microspheres
- Applicant
- Celonova Biosciences, Inc.
San Antonio, TX, US - Received
- May 9, 2014
- Decision date
- August 7, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252812 | UniPearls® Embolic MicrospheresKRD · Traditional | Suzhou Haowei Medical Technology Co., Ltd. | 07/31/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | Boston Scientific Corporation | 07/24/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | Medtronic, Inc. | 06/24/2026SE |
| K260635 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 06/12/2026SE |
| K260508 | LOBO Vascular Occlusion SystemKRD · Traditional | Okami Medical, Inc. | 04/10/2026SE |
| K253511 | Concerto Versa Detachable CoilKRD · Traditional | Medtronic, Inc. | 01/14/2026SE |
| K253677 | Tembo Embolic SystemKRD · Special | Instylla, Inc. | 12/15/2025SE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | Boston Scientific Corporation | 10/30/2025SE |
| K250209 | Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional | Canyon Medical, Inc. | 09/23/2025SE |
| K250133 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 07/09/2025SE |
More from Nuvascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K133447 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresNAJ · Traditional | 02/24/2014SE |
| 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, Oncozene Microspheres cleared by the FDA?
Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Oncozene Microspheres (K141209) received a 510(k) decision of Substantially Equivalent on August 7, 2014, 90 days after the submission was received.
What is the product code of K141209?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.