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

    CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER

    K Number: K953663 · Decision Sep 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    10
    Review Days
    408

    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
    CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
    K Number
    K953663
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cordis Webster, Inc.
    Date Received
    August 7, 1995
    Decision Date
    September 18, 1996
    Product Code
    DRF
    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
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

    Similar 510(k) Clearances

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

    Vision-MR™ Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAGiC Sweep™ EP Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIKING™ Fixed Curve Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nordica PV Cryo Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cosine-10TM Diagnostic Catheter

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

    Other Clearances by Cordis Webster, Inc.

    K Number Device Name
    K992965 CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
    K991531 CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
    K982740 CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S
    K982415 CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210
    K980961 CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.
    K970264 CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM
    K955817 CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER
    K954390 CORDIS WESTER STAR CATHETER
    K953768 CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER