BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ABIOMED, INC.

    Reg #: 1220648 · FEI: 1220648 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    ABIOMED, INC.
    Registration Number
    1220648
    FEI Number
    1220648
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    22 Cherry Hill Dr
    City
    DANVERS
    State
    MA
    ZIP
    01923
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223872
    PMA Number
    P170011

    Owner / Operator

    Firm Name
    ABIOMED, INC.
    Operator Number
    1220648
    Address
    22 CHERRY HILL DR., --
    City
    Danvers
    State
    MA
    Postal Code
    01923
    Country
    US
    Correspondent
    Anshul Shah

    Products

    Device Name Product Code
    Temporary Non-Roller Type Right Heart Support Blood Pump PYX
    Instruments, Surgical, Cardiovascular DWS
    Temporary Non-Roller Type Left Heart Support Blood Pump OZD
    Introducer, Catheter DYB
    Medical Device Data System OUG
    Device, Intravascular Catheter Securement KMK
    Control, Pump Speed, Cardiopulmonary Bypass DWA
    Oxygenator, Cardiopulmonary Bypass DTZ
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF

    Proprietary Names

    Impella RP Impella RP with SmartAssist Impella RP Flex with SmartAssist Automated Impella Controller (AIC) Impella 2.5 Impella 5 Impella LD Impella CP Impella CP with SmartAssist Impella 5.5 with SmartAssist Low Profile Companion Sheath Abiomed 14Fr Low Profile Introducer Set Impella Connect Abiomed 23 Fr Introducer Impella CP Introducer OXY-1 System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility