BEUDAMED
    Product Code: QJP FDA class 2 21 CFR 870.1250

    Catheter, Percutaneous, Neurovasculature

    Cardiovascular

    The Catheter, Percutaneous, Neurovasculature is a Class 2 cardiovascular device intended to provide vascular access to the neurovasculature for interventional or diagnostic procedures, such as cerebral angiography or neurointerventional therapy. It requires 510(k) clearance and is regulated under 21 CFR 870.1250, reviewed by the Neurology panel under the Cardiovascular medical specialty. The product code is QJP. The device is not an implant and is not flagged as life-sustaining.

    View on FDA
    510(k)s
    77
    FEI Numbers
    61
    Registration Numbers
    61
    Unique Applicants
    45
    Years Active
    5

    Basic Information

    Product Code
    QJP
    Device Class
    FDA class 2
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    To provide vascular access to the neurovasculature for interventional or diagnostic procedures

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 77 510(k) clearances via K numbers.

    K Number Device Name
    K251560 FUBUKI XF-R Neurovascular Long Sheath
    K251240 Branchor X Balloon Guide Catheter
    K251044 93 NeuFlex Catheter
    K242392 PATH BGC
    K242289 Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
    K243593 AXS Lift Intracranial Base Catheter
    K242051 VersaD Delivery Catheter
    K243577 Radical the Dude 8F Guide Catheter
    K243297 APRO 70 Swift Catheter
    K241388 Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
    K242376 Next Generation Access Platform
    K241768 Broadway 8 Catheter
    K241637 Echo Intracranial Base Catheter
    K242033 Access25™ Delivery Microcatheter
    K240971 87 NeuGlide Catheter
    K242301 Socrates 38 Catheter
    K240746 Neurovascular Access System Family
    K240711 Zipline Access Catheter
    K241244 CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter
    K240529 8F Modified Sheath System
    K234074 Next Generation Access Catheter
    K240948 TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
    K232542 Wedge XL Delivery Catheter
    K233982 CEREGLIDE 92 Catheter System
    K233924 EMBOGUARD Balloon Guide Catheter
    K233201 MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)
    K231056 Esperance Distal Access Catheter
    K231218 Distal Access Catheter
    K233205 Distal Access Catheter
    K233648 Millipede 088 Access Catheter
    K231179 Slinky Catheter
    K231393 Radical the Dude 7F Guide Catheter
    K230726 CEREGLIDE 92 Intermediate Catheter
    K231802 Millipede 088 Access Catheter
    K222948 Q Distal Access Catheter
    K230775 SOFIA EX Intracranial Support Catheter
    K230609 NG Delivery Catheter
    K223560 Plato 17 Microcatheter
    K231583 Route 92 Medical Full Length 054 Access System
    K230322 SelectFlex Neurovascular Access System Family
    K231168 TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
    K221930 CEREGLIDE 71 Intermediate Catheter
    K223275 CELLO II Balloon Guide Catheter
    K221822 BENCHMARK BMX81 Access System
    K221951 Branchor Balloon Guide Catheter
    K222743 Route 92 Medical Full Length 070 Access System
    K214048 Millipede 088 Access Catheter
    K213390 Benchmark BMX96 Access System
    K212288 Minjie Catheter System
    K213065 Distal Access Catheter
    K212838 Benchmark Intracranial Access System
    K220807 Imperative Care Radial 088 Access System
    K203842 Bendit21 Microcatheter
    K213589 FUBUKI XF Neurovascular Long Sheath
    K213314 CerusEndo Microcatheter (027)
    K202926 Micro Catheter
    K212340 EMBOGUARD Balloon Guide Catheter
    K212402 MIVI Q Distal Access Catheter
    K203723 Branchor Balloon Guide Catheter
    K211594 Trevo Trak 21 Microcatheter
    K213451 Spartan MC 0165
    K212224 TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
    K202752 AXS Vecta 46 Intermediate Catheter
    K202916 Balloon Guiding Catheter
    K211893 SelectFlex Neurovascular Access System Family
    K210635 Route 92 Medical Full Length 088 Access System
    K203764 TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
    K203840 BOSS 8F Balloon Guide Catheter
    K203043 Route 92 Medical 070 Access System
    K201682 RIST Radial Access Catheter
    K201518 Route 92 Medical 088 Access System
    K201076 Anchor Dual Lumen Guidewire Catheter
    K200910 BOSS Balloon Guide Catheter
    K200417 RIST Radial Access Catheter
    K200121 Route 92 Medical 088 Access System, 110 cm
    K200206 AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
    K192804 CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm

    FEI Numbers

    This FDA classification entry is associated with 61 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 61 registration numbers. Click on an entry to view related FDA registrations.