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510(k) Data Aggregation
K Number
K030636Device Name
C-PORT
Manufacturer
CLINISURG VASCULAR PRODUCTS, LLC
Date Cleared
2003-06-05
(97 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
CLINISURG VASCULAR PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The C-Port family of products will be used as a subcutaneously implanted device where repeated access to the vascular system is the therapy of choice for delivery of medications, fluids, nutritional solutions and blood products or withdrawal of blood.
Device Description
The CliniSurg family of Vascular Access devices is a group of subcutaneously implantable ports with a catheter either pre-attached or attachable for application by physicians in indicated therapies. The device has a port that is a titanium chamber with a silicone membrane designed for repeated needle insertion. The port comes in various sizes to enable use with larger adults or smaller pediatric patients or the more emaciated adult patient. A higher or lower profile device is chosen by patient evaluation. The port is connected to a catheter that is long enough to insert into the vena cava for positioning to enable fluid infusion into larger vessels. The catheter is fixed to the port with a hub either during a procedure to implant the device or it comes pre-assembled (physician choice for use). The catheter has a series of radiopaque marks to enable depth determination when the catheter is inserted into the vena cava. A kit is provided to aid in catheter placement, insertion, and port implantation. Items such as syringes, vein introducers, trocars, guide wires, sheaths, fixation hubs, Huber needles, and infusion sets may be part of a total kit.
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