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510(k) Data Aggregation
K Number
K140286Device Name
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
Manufacturer
CORDIS, A JOHNSON & JOHNSON CO.
Date Cleared
2014-03-07
(30 days)
Product Code
DTK
Regulation Number
870.3375Why did this record match?
Applicant Name (Manufacturer) :
**CORDIS, A JOHNSON **& JOHNSON CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated, .
- Failure of anticoagulant therapy for thromboembolic disease, .
- Emergency treatment following massive pulmonary embolism where anticipated benefits of . conventional therapy are reduced,
- Chronic. recurrent pulmonary embolism where anticoagulant therapy has failed, or is . contraindicated.
The OPTEASE Filter may be retrieved according to the instructions supplied in the Section labeled: "Optional Procedure for Filter Retrieval".
The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of the radiopaque contrast media to the vena cava.
Device Description
The Cordis OPTEASE® Vena Cava Filter (Filter) is designed for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (IVC). The self-centering OPTEASE® Filter is laser cut from nickel titanium alloy (Nitinol) tubing. The proximal and distal baskets of the OPTEASE® Filter, consisting of struts in a six-diamond shape configuration, are designed for optimal clot capture. The constrained filter is supplied in a unidirectional storage tube that is loaded as a system into the hemostasis valve of the sheath introducer. The subject device is comprised of the filter packaged within a unidirectional storage tube, introduction kit that includes angiographic vessel dilator, catheter sheath introducer and obturator. The OPTEASE® Retrieval catheter is packaged separately.
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K Number
K013581Device Name
CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
Manufacturer
CORDIS, A JOHNSON & JOHNSON CO.
Date Cleared
2001-11-28
(30 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
**CORDIS, A JOHNSON **& JOHNSON CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cordis AVIATOR Peripheral Dilatation catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Device Description
The AVIATOR Peripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The second lumen, located only in the distal shaft, permits the use of a .014" diameter guidewire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The catheter shaft has a distal port (hole) near the distal end that accesses the guidewire lumen. The guidewire lumen begins at the distal port and ends at the distal tip. This "rapid exchange" design allows insertion and removal of the catheter without extension of the guidewire.
The balloon has radiopaque marker(s) to aid in positioning the balloon. The balloon is further designed to provide an expandable segment of known diameter and length at a specific pressure.
The design of this catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
A flushing needle accessory is also provided with the device to facilitate flushing/lubricating the catheter's inner guidewire lumen prior to use.
The AVIATOR Peripheral Dilatation Catheter is provided sterile and is intended for single use only.
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K Number
K012090Device Name
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
Manufacturer
CORDIS, A JOHNSON & JOHNSON CO.
Date Cleared
2001-08-01
(27 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
**CORDIS, A JOHNSON **& JOHNSON CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree.
Device Description
The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA® PRO Balloon Catheter is recommended for the delivery of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent.
The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is hand crimped upon its recommended balloon catheter delivery device. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and removed.
The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is provided sterile (via gamma irradiation) and is intended for single use only.
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K Number
K992755Device Name
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE
Manufacturer
CORDIS, A JOHNSON & JOHNSON CO.
Date Cleared
1999-09-15
(30 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
**CORDIS, A JOHNSON **& JOHNSON CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cordis PALMAZ® CORINTHIAN™ IQ Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
Device Description
The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is a balloonexpandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis POWERFLEX® Plus and OPTA® LP Balloon Catheters are recommended for the delivery of the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent.
The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is mounted upon its recommended balloon catheter delivery device via the use of accessory devices - plastic crimping tubes, which are provided with the packaged stent, and crimping tools, which are provided separately. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and removed.
The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is provided sterile and is intended for single use only.
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