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510(k) Data Aggregation
K Number
K092306Device Name
SECURACATH UNIVERSAL
Manufacturer
INTERRAD MEDICAL, INC.
Date Cleared
2010-07-09
(345 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
INTERRAD MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SecurAcath Universal Device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.
Device Description
The SecurAcath Universal is a single use, sterile device for securing indwelling catheters. The device is a stand-alone accessory to percutaneous indwelling catheters and consists of a subcutaneous anchor that is deployed in the subcutaneous space at the catheter access site to reduce catheter migration and pull-out.
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K Number
K083081Device Name
MODIFICATION TO SECURACATH, MODEL: SPK01
Manufacturer
INTERRAD MEDICAL, INC.
Date Cleared
2009-03-04
(139 days)
Product Code
OKC
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
INTERRAD MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SecurAcath PICC is indicated for short or long term peripheral access to the central venous system. The catheter may be used for intravenous therapy, power injection of contrast media, blood sampling and/or infusion therapy. The maximum recommended infusion rate is 5 m/sec and the maximum pressure of power injectors may not exceed 300 psi. The SecurAcath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.
Device Description
The SecurAcath is a single use, sterile, flexible PICC catheter with a useful lengths of up to 55 cm. The length of the catheter has markings at 1 cm interval to allow the user to trim the catheter to the required length. The catheter has a built in subcutaneous securement mechanism to stabilize and keep the catheter in place. The catheter has two lumens which are identical in properties and characteristics.
The device is compatible with all 0.018" and smaller guidewires. The proximal end of the catheter has the standard radiology PICC configuration plus the activation mechanism of the securement system built into the Y-body. The catheter has been tested to be compatible with MRI (MR conditional) and use with power contrast injectors.
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K Number
K082047Device Name
SECURACATH CATHETER, MODEL SPK01
Manufacturer
INTERRAD MEDICAL, INC.
Date Cleared
2008-09-30
(74 days)
Product Code
OKC
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
INTERRAD MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SecurAcath is a PICC and is indicated for short and long term use in peripheral vessels to access the central venous system. The catheter may be used for blood sampling and/or infusion therapy. The SecurAcath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.
Device Description
The SecurAcath is a single use, sterile, flexible PICC catheter with a useful lengths of up to 60 cm. The length of the catheter has markings at 1 cm interval to allow the user to trim the catheter to the required length. The catheter has a built in subcutaneous securement mechanism to stabilize and keep the catheter in place. The catheter has two lumens which are identical in properties and characteristics. The device is compatible with all 0.018" and smaller guidewires. The proximal end of the catheter has the standard radiology PICC configuration plus the activation mechanism of the securement system built into the Y-body.
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