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

    MINISTIK MINI PUNCTURE SET CATALOG CODE #57505

    K Number: K871137 · Decision Jul 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    56
    Review Days
    118

    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
    MINISTIK MINI PUNCTURE SET CATALOG CODE #57505
    K Number
    K871137
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Dlp, Inc.
    Date Received
    March 20, 1987
    Decision Date
    July 16, 1987
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

    Similar 510(k) Clearances

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

    InQwire Amplatz Guide Wire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Enroute 0.014'' Transcarotid Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EmeryGlide™ (EG18008901)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

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

    Other Clearances by Dlp, Inc.

    K Number Device Name
    K973485 CLEARVIEW BLOWER/MISTER
    K964445 OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
    K953945 RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET
    K950754 MACRO SUCTION TUBE MODEL NO 10061
    K934215 CONTAIN-OR
    K915268 CATHETER TWO STAGE VENOUS RETURN
    K913077 LANCASTER COOLING JACKET, CAT. CODE #13500/13501
    K914608 BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120
    K913098 APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501
    K912229 IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003
    Search all 56 clearances from Dlp, Inc. →