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510(k) Data Aggregation
K Number
K080645Device Name
STD MED PRIMO PORT POLY
Manufacturer
Date Cleared
2008-05-02
(57 days)
Product Code
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
STD MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The STD Med Primo Port is a totally-implantable vascular access device designed to provide long term, repeated access to the vascular system.
The STD Med Primo Port Poly is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Device Description
The device described in this 510(k) consists of a a modified sterile, single use, implantable port, with catheter and catheter locks. The port is introduced into the vascular system and attached to the port stem using a catheter lock. The port is then sutured under the skin in the area of the subclavian fossa. The port is accessed percutancously usina a non-coring needle that penetrates a silicone rubber septum at the top of the port. The port system is the mechanism with which fluids can pass into and out of the central venous system.
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K Number
K070911Device Name
STD MED PRIMO PORT
Manufacturer
Date Cleared
2007-08-10
(130 days)
Product Code
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
STD MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The STD Med Primo Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I. V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
Device Description
The STD Med Primo Port kit contains 1 Titanium port, 1 catheter of choice, and 2 corresponding catheter locks, The catheter is introduced into the vascular system and attached to the port stem using a catheter lock. The port is then sutured under the skin in area of the subclavian fossa. The port is accessed percutaneously using a noncoring needle that penetrates a silicone rubber septum at the top of the port. The port system is the mechanism with which fluids can pass into and out of the central venous system.
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