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510(k) Data Aggregation
K Number
K070020Device Name
COMCASET-P SAFETY IV CATHETER
Manufacturer
Date Cleared
2007-08-16
(225 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
PITANGO MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ComCaSet-P Safety IV Catheter is indicated to sample blood, monitor blood pressure, or administer fluids intravenously. The ComCaSet-P Safety IV Catheter may be used for any patient population with consideration given to adequacy of the vascular anatomy appropriateness for the solution being administered and duration of the therapy. The ComCaSet-P Safety IV Catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the catheter hub and needle assembly components are withdrawn, the shielding mechanism is activated and the needle retracts into the shielding tube.
Device Description
The ComCaSet-P Safety IV Catheter consists of several parts common to most IV catheters: stainless steel needle, Teflon catheter tube with hub and the catheter body. In addition, the ComCaSet-P Safety IV Catheter has a safety locking mechanism which enables the needle and the flash chamber to retract into a safety barrel. Disconnecting the needle assembly and catheter hub from the catheter releases the latex-free elastic rubber band and allows the needle and flash chamber to retract quickly into the safety barrel.
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K Number
K062108Device Name
COMCASET SAFETY IV CATHETER
Manufacturer
Date Cleared
2006-08-08
(15 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
PITANGO MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ComCaSet Safety IV Catheter is indicated to sample blood, monitor blood pressure, or administer fluids intravenously. The ComCaSet Safety IV Catheter may be used for any patient population with consideration given to adequacy of the vascular anatomy appropriateness for the solution being administered and duration of the therapy. The ComCaSet Safety IV Catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the catheter hub and needle assembly components are withdrawn, the user activates the shielding mechanism and the needle retracts into the shielding tube.
Device Description
The ComCaSet Safety IV Catheter consists of several parts common to most IV catheters: stainless steel needle. Teflon catheter tube with hub and the catheter body. In addition, the ComCaSet Safety IV Catheter has a safety locking mechanism which, when activated, enables the needle and the flash chamber to retract into a safety barrel. The activation element holds the needle assembly in the forward position until the user activates the device. Pulling the activator releases the latexfree elastic rubber band and allows the needle and flash chamber to retract quickly into the safety barrel. In this way user maintains control of the process by determining when to activate the safety mechanism. The product is available in seven gauges identified also by specific colors.
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