BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SURMODICS, INC.

    Reg #: 3014687026 · FEI: 3014687026 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    11
    Establishment Types
    5
    Classifications
    6

    Registration Details

    Registration Name
    SURMODICS, INC.
    Registration Number
    3014687026
    FEI Number
    3014687026
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7905 Golden Triangle Drive Suite 190
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173560
    PMA Number
    P210025

    Owner / Operator

    Firm Name
    SURMODICS, INC.
    Operator Number
    9070604
    Address
    9924 WEST 74TH STREET, --
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
    Catheter, Continuous Flush KRA
    Introducer, Catheter DYB
    Catheter, Angioplasty, Peripheral, Transluminal LIT

    Proprietary Names

    Pounce™ Thrombectomy SurVeil™ Drug-Coated Balloon Sublime™ Microcatheter Pounce™ LP Thrombectomy Pounce™ Venous Thrombectomy System Pounce Sheath Sublime™ Radial Access Guide Sheath SublimeTM Radial Access 018 RX Dilatation Catheter Pounce™ XL Thrombectomy SublimeTM Radial Access 014 RX PTA Dilatation Catheter Pounce™ Sheath

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)