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

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    K Number: K142120 · Decision Aug 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    175
    Applicant Total
    59
    Review Days
    24

    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
    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
    K Number
    K142120
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AtriCure, Inc.
    Date Received
    August 4, 2014
    Decision Date
    August 28, 2014
    Product Code
    FZP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FZP Clip, Implantable

    Similar 510(k) Clearances

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

    InnoClip Clip Applier

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    InnoClip Disposable Clip Applier

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Disposable Polymer Ligation Clips

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GEM ZIPCLIP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SOLID CLIP™ Single Use Clip Applier

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by AtriCure, Inc.

    K Number Device Name
    K252056 Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)
    K250371 cryoICE cryoXT cryoablation probe (cryoXT)
    K243860 AtriClip PRO-Mini LAA Exclusion System (PROM)
    K243157 AtriCure cryoICE BOX (ACM)
    K234151 Isolator Synergy EnCapture Ablation System (EMH)
    K234125 AtriClip FLEX-Mini LAA Exclusion System (ACHM)
    K233959 EPi-Ease Epicardial Access Device (EAS)
    K233407 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)
    K233170 cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
    K221358 Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
    Search all 59 clearances from AtriCure, Inc. →