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

    ASPIRA PERITONEAL DRAINAGE SYSTEM

    K Number: K081288 · Decision Jul 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    14
    Applicant Total
    645
    Review Days
    72

    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
    ASPIRA PERITONEAL DRAINAGE SYSTEM
    K Number
    K081288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    May 7, 2008
    Decision Date
    July 18, 2008
    Product Code
    PNG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

    Similar 510(k) Clearances

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

    ASEPT® Glide Peritoneal Drainage System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Passio Pump Drainage System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ASEPT Peritoneal Drainage System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Aspira Peritoneal Drainage System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PleurX Peritoneal Catheter System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by C.R. Bard, Inc.

    K Number Device Name
    K254076 BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
    K252971 Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
    K251864 Rubber Utility Catheter
    K251186 Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
    K241334 Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,
    K230356 Aspirex™ Thrombectomy System
    K223177 Highlander™ 014 PTA Balloon Dilatation Catheter
    K222793 WavelinQ™ Generator
    K220270 Aspirex Thrombectomy System
    K213203 Provena(TM) Midline Catheter
    Search all 645 clearances from C.R. Bard, Inc. →