BEUDAMED
    Product Code: PNG FDA class 2 21 CFR 876.5630

    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

    Gastroenterology, Urology

    The Peritoneal Drainage Catheter For Refractory Ascites, Long-Term Indwelling (product code PNG) is a Class 2 gastroenterology and urology device intended for long-term drainage of refractory ascites from the peritoneal cavity, regulated under 876.5630. It requires 510(k) clearance and is flagged as both an implant and a life-sustaining/life-supporting device, given its indwelling role in managing refractory ascites. The device falls within the gastroenterology and urology specialty.

    View on FDA
    510(k)s
    15
    FEI Numbers
    28
    Registration Numbers
    28
    Unique Applicants
    8
    Years Active
    19

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    Basic Information

    Product Code
    PNG
    Device Class
    FDA class 2
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    Definition

    For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 15 510(k) clearances via K numbers.

    K Number Device Name
    K241278 ASEPT® Glide Peritoneal Drainage System
    K241946 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-
    K230319 Passio Pump Drainage System
    K221779 ASEPT Peritoneal Drainage System
    K212675 Aspira Peritoneal Drainage System
    K201155 PleurX Peritoneal Catheter System
    K162457 Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
    K160437 PleurX Peritoneal Catheter System
    K152105 Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
    K122422 PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
    K113854 PLEURX PERITONEAL CATHETER SYSTEM
    K110396 ASPIRA PERITONEAL DRAINAGE SYSTEM
    K093796 ASEPT PERITONEAL DRAINAGE SYSTEM
    K081288 ASPIRA PERITONEAL DRAINAGE SYSTEM
    K051711 PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS

    FEI Numbers

    This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.