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Sign in to claim this brandCelonova Biosciences, Inc.
United States·US-MF-000008827
Last updated May 23, 2026
What Celonova Biosciences, Inc. makes
Celonova Biosciences manufactures non-bioabsorbable embolization particles, including color-coded and opaque microspheres for targeted vascular occlusion, and bare-metal coronary artery stents for percutaneous revascularization.
The company’s portfolio includes Class II embolization devices and Class III coronary stents, authorised via FDA 510(k) clearances, PMA submissions, and UDI registrations. It operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Celonova Biosciences, Inc. manufacture?
Celonova Biosciences, Inc. specializes in two primary device categories: non-bioabsorbable embolization particles and bare-metal coronary artery stents. The embolization particles, such as the Embozene Microspheres (available in color-coded and opaque variants), are designed for targeted vascular occlusion, while the bare-metal coronary artery stents (e.g., Cobra PzF) are intended for percutaneous revascularization procedures. These devices are engineered to address specific clinical needs in interventional radiology and cardiology.
Where is Celonova Biosciences, Inc. based, and how does this affect its regulatory approach?
Celonova Biosciences, Inc. is headquartered in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulatory pathways, including 510(k) clearances for Class II devices like embolization particles and PMA submissions for Class III devices such as coronary stents. The company also registers its devices under the FDA’s Unique Device Identification (UDI) system, ensuring traceability and compliance with U.S. medical device regulations.
Which regulatory registries or databases list Celonova Biosciences’ devices?
Celonova Biosciences’ devices are listed in key U.S. regulatory databases, including the FDA’s 510(k) clearance registry for Class II embolization particles, the PMA submission registry for Class III coronary stents, and the UDI (Unique Device Identifier) database. These registries ensure transparency and compliance with FDA requirements for post-market surveillance and device tracking.
How are Celonova Biosciences’ devices classified under FDA regulations?
Celonova Biosciences’ devices fall into two primary FDA risk classes: Class II for embolization particles (e.g., Embozene Microspheres) and Class III for bare-metal coronary artery stents (e.g., Cobra PzF). Class II devices require a 510(k) clearance, demonstrating substantial equivalence to a predicate device, while Class III devices—considered higher risk—require a Premarket Approval (PMA) application, involving rigorous clinical data to ensure safety and effectiveness before market authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 5840 El Camino Real, Ste. 111, Carlsbad, United States
- Website
- celonova.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Erick Zumaya
- EUDAMED SRN
- US-MF-000008827
- FDA FEI Number
- —
- DUNS Number
- 168593429
Catalogue (82)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Embozene Microspheres (Color-Advanced) | 111020-S1 | FDA UDI | Class II | Active |
| Cobra PzF | 170-03-40012 | FDA UDI | Class III | Active |
| Cobra PzF | 170-03-40008 | FDA UDI | Class III | Active |
| Embozene Microspheres (Opaque) | 11010-S0 | FDA UDI | Class II | Active |
| ONCOZENE Microspheres | 11030-US1 | FDA UDI | Class II | Active |
| Cobra PzF | 170-03-35015 | FDA UDI | Class III | Active |
| ONCOZENE Microspheres | 10430-US1 | FDA UDI | Class II | Active |
| Embozene Microspheres (Color-Advanced) | 12010-S1 | FDA UDI | Class II | Active |
| Cobra PzF | 170-03-35008 | FDA UDI | Class III | Active |
| Cobra PzF | 170-03-35024 | FDA UDI | Class III | Active |
| Cobra PzF | 170-03-40030 | FDA UDI | Class III | Active |
| Cobra PzF | 170-03-30008 | FDA UDI | Class III | Active |
| Embozene Microspheres (Color-Advanced) | 19010-S1 | FDA UDI | Class II | Active |
| Embozene Microspheres (Color-Advanced) | 17010-S1 | FDA UDI | Class II | Active |
| Embozene Microspheres (Opaque) | 113010-S0 | FDA UDI | Class II | Active |
| Cobra PzF | 170-03-27530 | FDA UDI | Class III | Active |
| Embozene Microspheres (Opaque) | 15020-S0 | FDA UDI | Class II | Active |
| Cobra PzF | 170-03-35018 | FDA UDI | Class III | Active |
| Cobra PzF | 170-03-40015 | FDA UDI | Class III | Active |
| ONCOZENE Microspheres | 10420-US1 | FDA UDI | Class II | Active |
| Embozene Microspheres (Color-Advanced) | 15010-S1 | FDA UDI | Class II | Active |
| Cobra PzF | 170-03-27512 | FDA UDI | Class III | Active |
| ONCOZENE Microspheres | 10720-US1 | FDA UDI | Class II | Active |
| Embozene Microspheres (Opaque) | 113020-S0 | FDA UDI | Class II | Active |
| Cobra PzF | 170-03-27518 | FDA UDI | Class III | Active |
| Embozene Microspheres (Opaque) | 10720-S0 | FDA UDI | Class II | Active |
| Embozene Color-Advanced Microspheres, Embozene Opaque (non-Colored) Microspheres, Oncozene Microspheres | K141209 | FDA 510(k) | Class II | Active |
| Oncozene Microspheres 40um, 2ml, Oncozene Microspheres 75um, 2ml, Oncozene Microspheres 100um, 2ml, Oncozene Microsphere | K130307 | FDA 510(k) | Class II | Active |
| Embozene Microspheres | K073417 | FDA 510(k) | Class II | Active |
| Embozene Microspheres | K132675 | FDA 510(k) | Class II | Active |
| Embozene Color-Advanced Microspheres, Embozene Opaque (non-Colored) Microspheres | K133447 | FDA 510(k) | Class II | Active |
| COBRA PzF NanoCoated Coronary Stent System | P160014 | EUDAMEDFDA PMA | Class III | Active |
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