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Found 6 results
510(k) Data Aggregation
K Number
K250897Device Name
Koala Intrauterine Pressure Catheter (IPC-5000E)
Manufacturer
Clinical Innovations LLC
Date Cleared
2025-05-22
(58 days)
Product Code
HFN
Regulation Number
884.2700Why did this record match?
Product Code :
HFN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Koala Intrauterine Pressure Catheter is indicated for use on patients requiring intrapartum intrauterine pressure monitoring.
Device Description
The Koala Intrauterine Pressure Catheter is a disposable, sterile, single patient use intrauterine pressure monitoring catheter, designed for measurement of intrauterine contraction pressures. The catheter is designed with a pressure-sensing membrane cavity at the tip (mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. The Koala Intrauterine Pressure Catheters utilizes a reusable cable with a reusable pressure transducer which is connected at the other end of the device. The sensor, located on the tip of the catheter is a 360° sensor that registers pressure in all directions. The tip is made of soft, malleable urethane. There are no electronics in the catheter. Clinicians can disconnect the catheter while it is in the uterus and zero the monitor while the transducer is exposed to atmospheric pressure, providing a true zero reading. The Koala Intrauterine Pressure Catheter has two different, clear lumens, one for the amnioinfusion, to confirm proper placement via amniotic fluid flashback, and another channel for sensor-charging. The amnioinfusion port has a hydrophobic and a tethered replacement cap.
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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?
Product Code :
HFN
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?
Product Code :
HFN
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
K961424Device Name
INTRAN 500
Manufacturer
UTAH MEDICAL PRODUCTS, INC.
Date Cleared
1996-07-10
(89 days)
Product Code
HFN
Regulation Number
884.2700Why did this record match?
Product Code :
HFN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in "high risk" births.
Device Description
The UMP Intran 500 is the same device as Intran 400, Intran Plus, a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in "high risk" births. Intran-500 adds a molded clear plastic cylinder component which is attached to the catheter's amnio port, along with a plastic clip containing a color reference scale that fits over the plastic cylinder. The cylinder acts as a section in the liquid line that can be used by physicians for visualization of the color of a fluid sample drawn from the amniotic sac.
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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?
Product Code :
HFN
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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K Number
K955443Device Name
INTRAN PLUS
Manufacturer
UTAH MEDICAL PRODUCTS, INC.
Date Cleared
1996-02-20
(84 days)
Product Code
HFN
Regulation Number
884.2700Why did this record match?
Product Code :
HFN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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