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510(k) Data Aggregation
K Number
K091099Device Name
C-PORT - HP POWER INJECTABLE PORT
Manufacturer
PHS MEDICAL GMBH
Date Cleared
2009-05-22
(36 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
PHS MEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The C-Port™ "Power Injectable" 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, special fluids such as contrast enhancement fluids or for withdrawal of blood.
When used with a power injectable needle infusion set, the C-Port™ "Power Injectable" Port is indicated for power injection of contrast media using an 8.0Fr or 9.6Fr catheter. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle or 2 ml/s with a 22 gauge non-coring power injectable needle.
For CT diagnostic procedures, it is recommended that the number of CT "power injections" be limited to a maximum number of ten (10) accesses over the life of the device.
Device Description
The device has a port that is a titanium chamber with a silicone membrane for insertion. The port comes in a standard size to enable use with adult patients. A standard profile is preferable so the chamber enable use with adult pationis. Treatment to a catheter that is long enough to insert into the vena cava for positioning to enable fluid infusion into the heart and insert into the rena catheter is fixed to the port with a catheter lock during a larger vossels. The catheter has a senes of radiopaque marks procodire to ith determination when the catheter is inserted into the vena cava. to enable depth dolorhination whole can be cant insertion, and port implantation for A kit is provided to all hirea "sterile, single use". For product supplied as OEM bulk, non-sterile, the product is vacuum-packaged in a double bag format and built, non blonio, the prelabeler to kit and sterilize). Items such as syringes, vein introducers, trocars, guide wires, sheaths, fixation hubs, Huber needles, and infusion sets may be part of a total kit intended for sterilization.
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