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510(k) Data Aggregation
K Number
K070101Device Name
UNIBLATE ELECTROSURGICAL DEVICE
Manufacturer
RITA MEDICAL SYSTEMS, INC.
Date Cleared
2007-02-14
(35 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RITA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RITA Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
Device Description
The UniBlate Electrosurgical Device is a monopolar radiofrequency (RF) device that consists of a variably insulated electrode. The instrument has an attached electrical cable and infusion tubing set which connects the device directly to the RITA Medical 1500X RF generator and the IntelliFlow peristaltic pump respectively. The electrical cable provides RF energy and temperature feedback to the generator and the pump infuses normal saline through the infusion tubing set. The UniBlate Electrosurgical Device is a single use device.
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K Number
K062414Device Name
VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
Manufacturer
RITA MEDICAL SYSTEMS, INC.
Date Cleared
2007-02-01
(168 days)
Product Code
LJT, FPA
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
RITA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vortex® CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.
When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19Ga sizes, the Vortex® CT Port Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.
The LifeGuard® Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with the Vortex® CT Port Access System, the LifeGuard® Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, only models LG-19-75, LG-19-100, LG-20-75, LG-20-100, and LG-20-150 may be used at a maximum infusion rate of Sml/sec.
Device Description
The Vortex® CT Port is a Titanium port with a self sealing silicone rubber septum designed to maintain integrity after punctures with a non-coring needle. The port has a hollow area, or reservoir, under the septum through which fluid passes during infusion or aspiration. The Vortex design features a proprietary reservoir with rounded walls giving it a toroidal shape. The outlet stem is located tangential to the reservoir wall allows fluid to pass between the reservoir and the catheter. The Vortex® Port Access systems offer models with single lumen 7.5 French to 9.6 French catheters made from either polyurethane or silicone. The catheters all contain radiopacifiers, and depth markings.
The LifeGuard safety infusion set is a port access needle set with an integrated proprietary safety feature to prevent re-bound injury. The safety infusion set includes a huber needle, a winged housing, non-DEHP PVC extension legs, and a luer standard connector.
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K Number
K062579Device Name
OMNIPICC P.I.
Manufacturer
RITA MEDICAL SYSTEMS, INC.
Date Cleared
2006-11-28
(89 days)
Product Code
LJS, 80L
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
RITA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OmniPICCPI Peripherally Inserted Central Catheter is indicated for use in attaining short and long term vascular access for administration of medications, parenteral nutrition, IV fluids, blood products or blood withdrawal. The OmniPICCPI is indicated for power injection of contrast media at a maximum recommended infusion rate of 3ml/sec and maximum pressure or pounds per square inch (psi) of 300 psi.
Device Description
The Peripherally Inserted Central Catheter (OmmiPICC P.I.) kit includes a catheter and introduction components. The catheter is a percutaneous central venous catheter inserted peripherally. The catheter is comprised of radiopaque polyurethane tubing. The catheter is attached to an injection molded polyurethane hub with extension leg(s) for access via a luer lock device. Each product is packaged in a sterile tray with appropriately sized introducer components. This PICC product line includes externally communicating central venous catheters of 60 cm that is trimmable from the distal end with a single 4 Fr single and 5 Fr dual lumen configurations. These are tested to withstand power injection of 3ml/sec (4 Fr Single) to 5 ml/sec at a maximum power injection setting of 300 psi.
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K Number
K051102Device Name
OMNIPICC PI
Manufacturer
RITA MEDICAL SYSTEMS, INC.
Date Cleared
2005-11-23
(208 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
RITA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OmniPICC P.I. is intended to be used by medical professionals in patients who require either acute or long-term (chronic) peripheral central venous access for the infusion of medications, nutritional or other parenteral solutions, or blood products, and for the withdrawal of blood samples.
The OmniPICCPI Peripherally Inserted Central Catheter is indicated for use in attaining short and long term vascular access for administrations, parenteral nutrition, IV fluids, blood products or blood withdrawal. The catheter may be inserted via the basilic, cephalic and medial veins of the upper extremity. The catheter is intended for implantation dwell time of shorter or greater than 30 days. The maximum recommended infusion rate is 5ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
The OmniPICCPI is indicated for power injection of contrast media at a maximum recommended infusion rate of 5ml/sec and maximum pressure or pounds per square inch (psi) of 300 psi.
Device Description
The Peripherally Inserted Central Catheter (OmniPICC P.I.) kit includes a catheter and introduction components. The catheter is a percutaneous catheter inserted peripherally. The catheter is comprised of radiopaque polyurethane tubing. The catheter is attached to an injection molded polyurethane hub with extension leg(s) for access via a luer lock device. Each product is packaged in a sterile tray with appropriately sized introducer components. This PICC product line includes externally communicating central venous catheters of 60 cm that is trimmable from the distal end with a single 5 Fr lumen configuration. These are tested to withstand power injection of 5 cc/sec at a maximum power injection setting of 300 psi.
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K Number
K050176Device Name
VORTEX EZ VASCULAR ACCESS PORT
Manufacturer
RITA MEDICAL SYSTEMS, INC.
Date Cleared
2005-02-25
(30 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
RITA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vortex® EZ Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.
Device Description
The Vortex® EZ Port Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex® EZ Port is available in a Delrin port body configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The port base is crafted of silicone so that the port can be sutured to the underlying tissue anywhere around this base. A pre-attached or a detached/attachable catheter is offered in either polyurethane or silicone models with or without a highly radiopaque tip molded on. The products are packaged in sterile trays with introduction components.
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