FDA Registration
Active
🇺🇸 United States
Cerenovus, Inc.
Reg #: 1226348
·
FEI: 3002947440
·
Expires 2026
Products
7
Proprietary Names
15
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- Cerenovus, Inc.
- Registration Number
- 1226348
- FEI Number
- 3002947440
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 325 Paramount Drive
- City
- RAYNHAM
- State
- MA
- ZIP
- 02767
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133625
- PMA Number
- P990040
Owner / Operator
- Firm Name
- Cerenovus, Inc.
- Operator Number
- 9026915
- Address
- 6303 Waterford District Dr Ste 315, --
- City
- Miami
- State
- FL
- Postal Code
- 33126
- Country
- US
- Correspondent
- Samuel Shimp
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2014-03-14 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2014-03-14 |
| Intracranial Aneurysm Flow Diverter | OUT | Class 3 | Unknown | No | 2018-08-09 |
| Intracranial Neurovascular Stent | NJE | Class f | Unknown | No | 2014-04-04 |
| Neurovascular Liquid Embolic Agent | SGU | Class 3 | Unknown | No | 2008-10-23 |
| Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | KGG | Class 3 | Unknown | No | 2008-10-23 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2008-10-23 |
Proprietary Names
NEUROSCOUT Steerable Guidewire
AGILITY Steerable Guidewire
BRAVO Flow Diverter
NeuroScout Steerable Guidewire
CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System
Neuroscout Steerable Guidewire
Agility Steerable Guidewire
Essence Guidewires
Agility (0.10)
TRUFILL n-Butyle Cyanoacrylate
Agility (0.16) Steerable Guidewires
TRUFILL DCS Syringe II
TRUFILL Syringe
Enterprise VRD & DS
Agility (14)
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only