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

    Langston dual lumen catheter

    K Number: K221470 · Decision Jun 17, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    11
    Review Days
    28

    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
    Langston dual lumen catheter
    K Number
    K221470
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Solutions, LLC
    Date Received
    May 20, 2022
    Decision Date
    June 17, 2022
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

    Similar 510(k) Clearances

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

    Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arterial Pressure Monitoring Set/Tray

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DualView Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    pNOVUS 21 Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Impress Angiographic Catheter

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

    Other Clearances by Vascular Solutions, LLC

    K Number Device Name
    K233729 Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58
    K230637 Wattson temporary pacing guidewire (2250)
    K220647 GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
    K212167 R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
    K212211 Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
    K210647 SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter
    K193119 Twin-Pass Dual Access Catheter
    K200720 D-Stat Radial Topical Hemostat
    K191560 Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter
    K182570 Venture 0.014 Catheter
    Search all 11 clearances from Vascular Solutions, LLC →