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

    HEIFETZ ANEURYSM CLIP, LMM BLADE

    K Number: K790413 · Decision Mar 16, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    35
    Applicant Total
    140
    Review Days
    18

    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
    HEIFETZ ANEURYSM CLIP, LMM BLADE
    K Number
    K790413
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Edward Weck, Inc.
    Date Received
    February 26, 1979
    Decision Date
    March 16, 1979
    Product Code
    HCH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCH Clip, Aneurysm

    Similar 510(k) Clearances

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

    Sugita AVM Microclips

    FDA 510(k)
    FDA Class 2 ·Neurology

    D-Clip; D-Clip Applier

    FDA 510(k)
    FDA Class 2 ·Neurology

    YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS

    FDA 510(k)
    FDA Class 2 ·Neurology

    CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP

    FDA 510(k)
    FDA Class 2 ·Neurology

    GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS

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

    Other Clearances by Edward Weck, Inc.

    K Number Device Name
    K915378 WECK TROCAR
    K914690 LM15(TM), CATALOG NUMBER - 523821
    K911915 HEMOCLIP II
    K914470 PNEUMO-SEAL(TM)
    K911272 ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705
    K902108 HEM-O-LOK(TM)
    K902232 WECK ELECTROSURGICAL GENERATOR #174200
    K897045 BOWIE-DICK TEST CARD CATALOG NUMBER 008018
    K871110 CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
    K851251 AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200
    Search all 140 clearances from Edward Weck, Inc. →