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

    Aspira Peritoneal Drainage System

    K Number: K212675 · Decision Dec 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    14
    Applicant Total
    178
    Review Days
    112

    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
    K212675
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    August 24, 2021
    Decision Date
    December 14, 2021
    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

    PleurX Peritoneal Catheter System

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

    Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

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

    Other Clearances by Merit Medical Systems, Inc.

    K Number Device Name
    K254073 StatSeal Disc
    K251802 STAR RF Ablation System
    K252892 SCOUT MD Surgical Guidance System
    K250853 Merit Syringe
    K251265 Resilience Fully Covered Esophageal Stent System
    K250909 Prelude Wave Hydrophilic Sheath Introducer
    K242873 Ventrax™ Delivery System
    K242229 Micro Ace Gold Advanced Micro Access System
    K241521 Prelude Small O.D. Introducer Guide Wire
    K233268 Impress Angiographic Catheter
    Search all 178 clearances from Merit Medical Systems, Inc. →