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

    COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER

    K Number: K983830 · Decision Apr 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    7
    Review Days
    168

    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
    COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
    K Number
    K983830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mallinckroot, Inc.
    Date Received
    October 30, 1998
    Decision Date
    April 16, 1999
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

    Similar 510(k) Clearances

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

    WAVE PTA Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Armada™ 14 NC PTA Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Amethyst HP PTA OTW 0.035 Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Amethyst HP PTA OTW 0.035 Catheter

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

    Other Clearances by Mallinckroot, Inc.

    K Number Device Name
    K894445 MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE
    K885348 A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL
    K885216 ATTACHABLE LANZ (TENTATIVE)
    K884159 SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT
    K884481 CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE
    K882130 FOLEY-TEMP(TM)