BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Cerenovus, Inc.

    Reg #: 3008264254 · FEI: 3008264254 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    40
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    Cerenovus, Inc.
    Registration Number
    3008264254
    FEI Number
    3008264254
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Calle Circuito Interior Norte #1820, Parque Industrial Salvarcar
    City
    Ciudad Juarez, Chihuahua Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K192804

    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
    Catheter, Percutaneous, Neurovasculature QJP
    Catheter, Continuous Flush KRA
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Thrombus Retriever NRY
    Device, Neurovascular Embolization HCG
    Catheter, Percutaneous DQY
    Device, Vascular, For Promoting Embolization KRD
    Wire, Guide, Catheter DQX

    Proprietary Names

    CEREBASE DA Guide Sheath Prowler Select Plus Straight 160cm EMBOGUARD Balloon Guide Catheter RAPID TRANSIT Infusion Catheter EmboTrap ll Revascularization Device POWLER Infusion Catheter TRANSIT Infusion Catheter TRUFILL DCS Orbit ENVOY 7Fr Guiding Catheter ENVOY Guiding Catheter TRUFILL DCS Prowler EX Microcatheter Prowler Select Plus Microcatheter Transit Infusion Catheter CEREGLIDE 71 Catheter System Orbit GALAXY Detachable Coil System CEREGLIDE 71 Intermediate Catheter Trufill DCS Orbit Detatchable Coil System CEREGLIDE 57 Intermediate Catheter CEREGLIDE 42 Intermediate Catheter CEREGLIDE 92 Intermediate Catheter EMBOTRAP III Revascularization Device Prowler Select ENVOY (DA) Distal Access Guiding Catheter ENVOY Distal Access (DA) Guiding Catheter ENVOY DA Guiding Catheter CEREGLIDE 92 Catheter System CEREPAK Detachable Coil Systems Cerenovus Large Bore Catheter EMBOVAC Aspiration Catheter Prowler XS Microcatheter Prowler Select LP ES Microcatheter Vascular Occlusion System Cerenovus Aspiration Tubing Set CERENOVUS Large Bore Catheter CERENOVUS Aspiration Tubing Set Essence Guidewires PROWLER Infusion Catheters Prowler Plus Infusion Catheter ENVOY Distal Access Guiding Catheter

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198