Search Results
Found 1 results
510(k) Data Aggregation
K Number
K982565Device Name
EASY TRANS TIP
Manufacturer
CARL SCHUH
Date Cleared
1998-09-22
(61 days)
Product Code
KXO
Regulation Number
884.2700Why did this record match?
Applicant Name (Manufacturer) :
CARL SCHUH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This intrauterine pressure monitoring catheter (IUPC) is for use on patients requiring intrapartum intrauterine pressure monitoring. Additionally it may be used for amniofusion and of Amniotic fluid sampling
Device Description
This disposable device is a catheter with a pressure transducer located at the distal tip to monitor the intrauterine pressure. The sensor/transducer is a thick film/ceramic strain gage connected via 4 leads to a connector in proximal end. This end connector interfaces with a reusable cable designed for the proper connection to the monitor in use. The IUPC has a separate fluid infusion and sampling lumen with three holes near the distal end that terminates at the proximal end with a luer fitting/cap. Incorporated in the connector housing at the proximal end is a switch for electronic zeroing of the transducer. This switch can also be used for periodic rezeroing of the system during use without the need for removal and replacement of the catheter. The distal end of the catheter holding the sensor is rounded and blunt while the catheter is soft, flexible polyurethane. The introducer, is designed to ease the insertion of the flexible catheter and is of a split sheath design for easy removal from the catheter after insertion. A Velcro attachment devise is supplied to attach the catheter firmly in place on the patients thigh to prevent inadvertent slippage or dislodgment during use.
Ask a Question
Page 1 of 1