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

    DIAGNOSTIC CATHETER SYSTEM

    K Number: K091250 · Decision May 22, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    26
    Review Days
    24

    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
    DIAGNOSTIC CATHETER SYSTEM
    K Number
    K091250
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinal Health, Inc.
    Date Received
    April 28, 2009
    Decision Date
    May 22, 2009
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    EOQ Bronchoscope (Flexible Or Rigid)

    Similar 510(k) Clearances

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

    FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SmartClip Delivery Catheter (ADR-1715)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    FUJIFILM Ultrasonic Endoscope EB-710US

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Cardinal Health, Inc.

    K Number Device Name
    K170198 Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
    K160411 Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
    K160875 Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
    K153316 Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
    K122696 POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
    K121897 PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
    K120934 PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
    K111878 PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
    K110272 STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
    K111015 STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
    Search all 26 clearances from Cardinal Health, Inc. →