BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Solitaire Platinum Revascularization Device

    K Number: K161879 · Decision Sep 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    108
    Applicant Total
    32
    Review Days
    75

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Solitaire Platinum Revascularization Device
    K Number
    K161879
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
    Date Received
    July 8, 2016
    Decision Date
    September 21, 2016
    Product Code
    NRY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NRY Catheter, Thrombus Retriever

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NRY), ordered by most recent decision date.

    Penumbra System (Thunderbolt Aspiration Tubing)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zenith Aspiration Catheter; Disposable Aspiration Tubing Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Lynx Aspiration Catheter System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Millipede System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tigertriever 25 Revascularization Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Esperance pHLO Aspiration System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

    K Number Device Name
    K241388 Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
    K243418 Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing
    K243080 Riptide Aspiration System
    K211990 Rist 071 Radial Access Guide Catheter
    K203432 Axium Detachable Coil; Axium Prime Detachable Coil
    K203358 Solitaire X Revascularization Device
    K202850 Concerto Versa, Detachable Coil
    K193576 Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
    K202318 Marathon Flow Directed Micro Catheter
    K201690 Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire
    Search all 32 clearances from Micro Therapeutics, Inc. d/b/a ev3 Neurovascular →