Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres 100UM, 2ML, Oncozene Microsphere
FDA 510(k) K130307 · Celonova Biosciences, Inc.
510(k) numberK130307
Submission
- Device name
- Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres 100UM, 2ML, Oncozene Microsphere
- Applicant
- Celonova Biosciences, Inc.
San Antonio, TX, US - Received
- February 7, 2013
- Decision date
- March 4, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K141209 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…KRD · Traditional | 08/07/2014SE |
| K133447 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresNAJ · Traditional | 02/24/2014SE |
| K132675 | Embozene MicrospheresKRD · Special | 10/03/2013SE |
| K073417 | Embozene MicrospheresKRD · Traditional | 12/15/2008SE |
Questions and answers
When was Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres 100UM, 2ML, Oncozene Microsphere cleared by the FDA?
Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres 100UM, 2ML, Oncozene Microsphere (K130307) received a 510(k) decision of Substantially Equivalent on March 4, 2013, 25 days after the submission was received.
What is the product code of K130307?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.