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510(k) Data Aggregation

    K Number
    K030691
    Device Name
    FETAL SPIRAL ELECTRODE, MODEL FSE07000
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Date Cleared
    2003-09-17

    (196 days)

    Product Code
    HGP
    Regulation Number
    884.2675
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For patients requiring fetal heart rate monitoring during labor.
    Device Description
    The device consists of a stainless steel spiral needle electrode. It is fixed to the fetal scalp by penetration of the skin by the spiral needle and thereby obtains the fetal ECG signal. A guide tube and a drive tube are required to place the electrode and are then removed before monitoring is begun. A stainless steel reference electrode is included close to the body housing the spiral electrode. The electrode is connected to the fetal monitor using a reusable adapter cable. A disposable maternal reference electrode connection is built into the adapter cable.
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    K Number
    K022023
    Device Name
    COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Date Cleared
    2003-01-07

    (201 days)

    Product Code
    KLA
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These catheters are for use on patients requiring gastrointestinal manometry testing. The Esophageal Pressure Catheter Model number GIM-6000E is for use with esophageal motility studies. The Ano-Rectal Pressure Catheter Model number GIM-6000A is for use in ano-rectal pressure studies.
    Device Description
    Gastrointestinal pressure catheters with pressure-sensing membrane cavities along the length of the catheter and a port for balloon inflation for the Anorectal model. This product is non-sterile, single patient use catheter. The system includes reusable cables with reusable pressure transducers.
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    K Number
    K003458
    Device Name
    SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Date Cleared
    2001-05-03

    (177 days)

    Product Code
    HGP
    Regulation Number
    884.2675
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K981260
    Device Name
    KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Date Cleared
    1998-09-22

    (169 days)

    Product Code
    HDB
    Regulation Number
    884.4340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use for fetal vacuum delivery assistance in conditions of: 1) dystocia, 2) uterine inertia, 3) maternal exhaustion (ineffective voluntary effort), or 4) maternal or fetal distress. Standard vacuum extraction Use for fetal vacuum extraction in conditions of 1) prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate, 2) presumed fetal jeopardy which is not considered to be severe, or 3) elective shortening of the second stage for selected maternal or fetal conditions. Trial of vacuum extraction Vacuum delivery should be regarded as a "trial" 1) if there is arrest of descent in the second stage and fetopelvic relationships are considered to be boderline, or 2) in a mid-pelvic extraction when position and station are known. Vacuum extraction should be abandoned and birth completed by cesarean section 1) if no descent (progress) of the head occurs after 2 tractions. 2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches ("pops-off") twice.
    Device Description
    The Kiwi Complete Vacuum Delivery Systems are fetal vacuum extractors having a cup to attach to the fetal head, a handle with which to apply withdrawal force, and a vacuum pump built into the handle of the cup/handle combination. This palm pump includes a method for easily generating a vacuum by pumping the handle with the palm. A vacuum indicator and a vacuum relief valve are also integral to the palm pump. Two styles of cups are available; one of soft silicone (VFE-6000S) and the other of the Malmstrom design (VFE-6000M).
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    K Number
    K974563
    Device Name
    COLPO CUP CVC-2000
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Date Cleared
    1998-03-02

    (87 days)

    Product Code
    HDP
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Demarcation of the cervical/vaginal junction during laparoscopy, laparoscopic-assisted vaginal hysterectomy, laparoscopic bladder surgery and other laparoscopic procedures where delineation of the junction is desired.
    Device Description
    The Colpo cup is an accessory to the ClearView Uterine Manipulator that is used to demarcate the cervical/vaginal junction during laparoscopy. This product is a sterile, single patient use device.
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    K Number
    K974389
    Device Name
    KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Date Cleared
    1998-02-19

    (90 days)

    Product Code
    HFN
    Regulation Number
    884.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
    Device Description
    An intrauterine pressure catheter with a pressure-sensing membrane cavity at the tip (either inside the catheter or mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. This product is a sterile, single patient use catheter. The system includes a reusable cable with a reusable pressure transducer.
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    K Number
    K973746
    Device Name
    PRE-FILLED SYRINGE FOR KOALA IUP
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Date Cleared
    1997-11-24

    (54 days)

    Product Code
    HFN
    Regulation Number
    884.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This accessory is used with a Koala Intrauterine Pressure System and is used in priming the catheter.
    Device Description
    The pre-filled Syringe is 10 cc syringe filled with 0.9% isotonic saline and is an accessory to the Koala Intrauterine Pressure System used in priming the catheter. This product is a sterile, single-use device.
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    K Number
    K954955
    Device Name
    STORC INTRAUTERINE PRESSURE CATHETER
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Date Cleared
    1996-04-17

    (173 days)

    Product Code
    HFN
    Regulation Number
    884.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
    Device Description
    STORC™ is a Disposable Intrauterine Pressure Monitoring System. This product is a sterile, single patient use catheter.
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