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

    Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter

    K Number: K221528 · Decision Aug 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    19
    Applicant Total
    136
    Review Days
    88

    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
    Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
    K Number
    K221528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5175
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edwards Lifesciences, LLC
    Date Received
    May 26, 2022
    Decision Date
    August 22, 2022
    Product Code
    DXF
    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
    DXF Catheter, Septostomy

    Similar 510(k) Clearances

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

    SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cross Wise™ Multi-Use RF Adapter Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VersaCross™ RF Wire

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

    Other Clearances by Edwards Lifesciences, LLC

    K Number Device Name
    K251326 Respiration Rate algorithm
    K253186 HemoSphere Nano Monitor (HSNANO1)
    K251982 Edwards MC3 Tricuspid annuloplasty ring (4900)
    K251688 Carpentier-Edwards Physio Annuloplasty Ring (4450)
    K242518 Hypertension Prediction Index (HePI) Algorithm
    K242909 FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
    K240078 Fogarty Thru-Lumen Embolectomy Catheter
    K233984 Acumen Assisted Fluid Management (AFM) Software Feature
    K233824 Swan-Ganz catheter
    K233819 Fogarty Venous Thrombectomy Catheters
    Search all 136 clearances from Edwards Lifesciences, LLC →