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

    NEEDLE'S EYE SNARE

    K Number: K961992 · Decision Dec 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    73
    Applicant Total
    34
    Review Days
    220

    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
    NEEDLE'S EYE SNARE
    K Number
    K961992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Pacemaker Corp.
    Date Received
    May 21, 1996
    Decision Date
    December 27, 1996
    Product Code
    DXE
    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
    DXE Catheter, Embolectomy

    Similar 510(k) Clearances

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

    Fogarty Thru-Lumen Embolectomy Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fogarty Fortis Arterial Embolectomy Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fogarty Arterial Embolectomy Catheter with Gate Valve

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fogarty Venous Thrombectomy Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Merlin Aspiration System

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

    Other Clearances by Cook Pacemaker Corp.

    K Number Device Name
    K970690 LOCKING STYLET 2
    K953417 MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
    K915188 MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD
    K905403 MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
    K863582 MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)
    K861559 SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS
    K860202 MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.
    K860466 MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.
    K854919 BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY
    K854132 COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS
    Search all 34 clearances from Cook Pacemaker Corp. →