FDA Registration
Active
🇺🇸 United States
Cerenovus, Inc.
Reg #: 3007628272
·
FEI: 3007628272
·
Expires 2026
Products
14
Proprietary Names
54
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- Cerenovus, Inc.
- Registration Number
- 3007628272
- FEI Number
- 3007628272
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6303 Waterford District Drive, Suites 215 and 315
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191237
- 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 |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2019-11-11 |
| Intracranial Aneurysm Flow Diverter | OUT | Class 3 | Unknown | No | 2018-08-09 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2008-10-23 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2008-10-23 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2010-06-11 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2010-06-11 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2011-06-14 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2024-08-13 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2021-09-03 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2008-10-23 |
| 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 |
| Intracranial Neurovascular Stent | NJE | Class f | Unknown | No | 2008-10-23 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2014-03-14 |
Proprietary Names
CERENOVUS Large Bore Catheter
BRAVO Flow Diverter
TRANSIT Infusion Catheter
Transit Infusion Catheter
Orbit GALAXY Detachable Coil System
Ascent Occlusion Ballon Catheter
Cerenovus Aspiration Tubing Set
Trufill DCS Orbit Detatchable Coil System
Prowler EX Microcatheter
Prowler Select Plus Microcatheter
POWLER Infusion Catheter
RAPID TRANSIT Infusion Catheter
Essence Guidewires
PROWLER Infusion Catheters
Agility (0.10)
YOGA Microcatheter
CEREBASE DA Guide Sheath
CERENOVUS Aspiration Tubing Set
GALAXY G3 XSFT Microcoil Delivery System
DELTAXSFT Microcoil Delivery System
MICRUSFRAME Microcoil Delivery System
GALAXY G3 Microcoil Delivery System
DELTAFILL Microcoil Delivery System
ENVOY (DA) Distal Access Guiding Catheter
ENVOY Distal Access (DA) Guiding Catheter
ENVOY DA Guiding Catheter
Agility (0.16) Steerable Guidewires
CEREPAK Detachable Coil Systems
CEREGLIDE 92 Intermediate Catheter
ENVOY Distal Access Guiding Catheter
GALAXY G3 Mini Microcoil Delivery System
Neuroscout Steerable Guidewire
Agility Steerable Guidewire
CEREGLIDE 71 Catheter System
NeuroScout Steerable Guidewire
ENVOY Guiding Catheter
CEREGLIDE 92 Catheter System
TRUFILL n-Butyle Cyanoacrylate
Enterprise VRD & DS
CEREGLIDE 57 Intermediate Catheter
CEREGLIDE 42 Intermediate Catheter
TRUFILL DCS
Prowler Plus Infusion Catheter
Prowler Select
CEREGLIDE 71 Intermediate Catheter
Vascular Occlusion System
Prowler XS Microcatheter
Prowler Select LP ES Microcatheter
NEUROSCOUT Steerable Guidewire
AGILITY Steerable Guidewire
ENVOY 7Fr Guiding Catheter
Agility (14)
Spectra (Micrusframe, Deltafill, Deltaxsft, Galaxy G3, Galaxy G3 XSFT, Galaxy G3 mini) Microcoil Delivery System
TRUFILL DCS Orbit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only