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

    ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER

    K Number: K132020 · Decision Oct 25, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    399
    Applicant Total
    190
    Review Days
    116

    Basic Information

    Device Name
    ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
    K Number
    K132020
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    COOK, INC.
    Date Received
    July 1, 2013
    Decision Date
    October 25, 2013
    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.

    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

    018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Finesse Injectable™ PTA Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oscar Peripheral Multifunctional Catheter system

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

    Other Clearances by COOK, INC.

    K Number Device Name
    K133130 BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
    K140593 ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
    K132592 FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
    K133597 CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
    K131772 CANTATA(R) 2.9 MICROCATHETER
    K131204 ADVANCE CS CORONARY SINUS INFUSION CATHETER
    K133634 SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
    K131201 ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
    K131206 COOK CERVICAL RIPENING BALLOON
    K132334 TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
    Search all 190 clearances from COOK, INC. →