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

    Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled

    K Number: K200205 · Decision May 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    69
    Applicant Total
    32
    Review Days
    106

    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
    Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled
    K Number
    K200205
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Sustainability Solutions
    Date Received
    January 28, 2020
    Decision Date
    May 13, 2020
    Product Code
    NLH
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NLH Catheter, Recording, Electrode, Reprocessed

    Similar 510(k) Clearances

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

    Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Stryker Sustainability Solutions

    K Number Device Name
    K260636 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
    K250898 Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)
    K241758 Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
    K241606 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
    K233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)
    K231621 Reprocessed ViewFlex Xtra ICE Catheter (D087031)
    K230255 Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019
    K230251 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
    K222019 Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
    K220481 Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
    Search all 32 clearances from Stryker Sustainability Solutions →