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

    HEART CATH TRAY, STERILE, DISPOSABLE

    K Number: K981441 · Decision Jul 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    44
    Review Days
    80

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    Basic Information

    Device Name
    HEART CATH TRAY, STERILE, DISPOSABLE
    K Number
    K981441
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trinity Laboratories, Inc.
    Date Received
    April 21, 1998
    Decision Date
    July 10, 1998
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Trinity Laboratories, Inc.

    K Number Device Name
    K974238 DENTAL TRAY, STERILE, DISPOSABLE
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    K972160 CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
    K970722 EYE TRAY
    K965201 O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
    K964921 BASIC BIOPSY TRAY. DISPOSABLE, STERILE
    K953929 MID-STREAM COLLECTION SET-STERILE
    K952058 STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
    K953070 WOUNDFOAM 4 X 4
    K951506 SUCTION CATHETER KIT, STERILE, SINGLE-USE
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