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510(k) Data Aggregation
K Number
K974533Device Name
TRIMPORT
Manufacturer
Date Cleared
1998-05-07
(156 days)
Product Code
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
GERARD MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Our TrimPort Systems are indicated for use whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.
Device Description
The Gerard Medical, Inc. TrimPort Implantable Access System is precision engineered to provide repeated access to the vascular system for both parenteral delivery of fluids and the withdrawal of venous blood. The implantable segments of the TrimPort System and comparable devices are the portal, the radiopaque catheter, and a locking catheter connector.
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K Number
K972555Device Name
CATHETER TUNNELER
Manufacturer
Date Cleared
1997-12-22
(168 days)
Product Code
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
GERARD MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A catheter tunneler is indicated whenever a surgeon would like to create a minimally invasive subcutaneous path for an implanted catheter. The implanting surgeon would oftentimes utilize the tunneler when implanting our TrimPort Systems. Our TrimPort Systems are indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.
Device Description
Gerard Medical plans to manufacture and market a catheter tunneler. This device will be used to create a subcutaneous path for an intraluminal catheter. The design of the device is such that the distal tip can separate subcutaneous tissues when manual force is applied in the direction of the tip along the length of the device proximal to the tip. The device has a means to connect the catheter in order to draw it through the subcutaneous tunnel. The tunneler may be constructed of any material (eg. metal or plastic) which permits separation of, and passage through, subcutaneous layers and is suitable for contact with this tissue. The initial device that we plan to produce and market is made of the plastic Delrin 500. We may, at a later date, provide an additional model that would consist of a medical grade stainless steel.
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