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

    Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

    K Number: K222232 · Decision Aug 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    21
    Review Days
    30

    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
    Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
    K Number
    K222232
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bard Access Systems, Inc.
    Date Received
    July 25, 2022
    Decision Date
    August 24, 2022
    Product Code
    LJS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

    Similar 510(k) Clearances

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

    Neonav ECG Tip Location System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PM2™ System with ECGuide™ Connector

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PM2+ System and SmartPICC Stylet

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Bard Access Systems, Inc.

    K Number Device Name
    K252478 Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port
    K251253 PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port
    K241353 PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set
    K242328 PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports
    K240146 BD Prevue™ II Peripheral Vascular Access System
    K210264 BD PowerPiCC Catheter
    K120882 SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE
    K100402 SITE-RITE VISION ULTRASOUND SYSTEM
    K071095 ASPIRA PLEURAL DRAINAGE SYSTEM
    K053589 LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING
    Search all 21 clearances from Bard Access Systems, Inc. →