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Found 8 results
510(k) Data Aggregation
K Number
K030691Device Name
FETAL SPIRAL ELECTRODE, MODEL FSE07000
Manufacturer
CLINICAL INNOVATIONS, INC.
Date Cleared
2003-09-17
(196 days)
Product Code
HGP
Regulation Number
884.2675Why 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
K022023Device 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
876.1725Why 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
K003458Device 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
884.2675Why 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
K981260Device 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
884.4340Why 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
K974563Device Name
COLPO CUP CVC-2000
Manufacturer
CLINICAL INNOVATIONS, INC.
Date Cleared
1998-03-02
(87 days)
Product Code
HDP
Regulation Number
884.4530Why 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
K974389Device 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
884.2700Why 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
K973746Device Name
PRE-FILLED SYRINGE FOR KOALA IUP
Manufacturer
CLINICAL INNOVATIONS, INC.
Date Cleared
1997-11-24
(54 days)
Product Code
HFN
Regulation Number
884.2700Why 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
K954955Device Name
STORC INTRAUTERINE PRESSURE CATHETER
Manufacturer
CLINICAL INNOVATIONS, INC.
Date Cleared
1996-04-17
(173 days)
Product Code
HFN
Regulation Number
884.2700Why 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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