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510(k) Data Aggregation
K Number
K131329Device Name
VECTOR PTA BALLOON DILATATION CATHETER
Manufacturer
R4 VASCULAR, INC.
Date Cleared
2013-06-06
(29 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
R4 VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vector 4 " PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.
The Vector Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents.
Device Description
The Vector" PTA Balloon Catheter is a high pressure, non-compliant balloon catheter with a radio-opaque coating on the balloon. The radio-opaque coating on the working length of the balloon minimizes or eliminates the need for using contrast solution to inflate the balloon. The radio-opaque coating delineates the working length of the balloon and provides continuous fluoroscopic visibility during balloon placement. Saline may be used to inflate the balloon without affecting visualization. Contrast mixture may be used at the discretion of · the physician.
It is a coaxial dual lumen over the wire balloon dilatation catheter. The central lumen, accommodates guide wires up to 0.035 inches in diameter while the outer lumen is the inflation'lument or the balloon. The catheter includes an atraumatic tip to ease advancement of the catheter, to and through the stenosis. The distal tip is visible under fluoroscopy.
The balloon is a high pressure composite balloon with a radio-opaque coating on the working length to help visualize placement within the lesion during both placement and inflation; without the use of contrast. The balloon's rated burst pressure is 30 atm.
The catheter is supplied sterile and non-pyrogenic. Different balloon sizes (5 mm to 10 mm) and catheter lengths (50 to 135 cm) are available. The proximal end of the catheter contains a hub with two female luer locks.
The device is compatible with 6-7F introducers. The introducer compatibility for each device size is listed on the device label itself. The materials used in the construction are biocompatible and latex free.
The modifications to the Vector TM PTA Balloon Dilatation Catherer are as follows.
- 1) The balloon will be coated with Parylene C coating, referred to throughout as Parylene, providing a natural lubricity for insertion and withdrawal through the introducer.
- 2) Each balloon catheter hub will be laser marked to include the balloon and introducer size, rated burst pressure and the product name, Vector" PTA. Balloon Catheter for customer convenience.
- 3) The balloon protector ID for the 5x40mm balloon was increased slightly.
There are no changes in the balloon catheter dimensions or significant changes in weight with these modifications ..
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K Number
K121385Device Name
VECTOR
Manufacturer
R4 VASCULAR, INC.
Date Cleared
2012-06-14
(37 days)
Product Code
LIT, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
R4 VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vector " Thi PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.
The Vector Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents
Device Description
The Vector" PTA Catheter is a high pressure, non-compliant balloon catheter with a radiopaque coating on the balloon. The radio-opaque coating on the working length of the balloon minimizes or eliminates the need for using contrast solution to inflate the balloon. The radioopaque coating delineates the working length of the balloon and provides continuous fluoroscopic visibility during balloon placement. Saline may be used to inflate the balloon without affecting visualization. Contrast mixture may be used at the discretion of the physician.
The Vector4™ PTA Balloon Dilatation Catheter is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon. The catheter includes an atraumatic tip to ease advancement of the catheter to and through the stenosis. The distal tip is visible under fluoroscopy.
The balloon is a high pressure composite balloon with a radiopaque coating on the working length to help visualize placement within the lesion during both placement and inflation without the use of contrast. The balloon's rated burst pressure is 30 atm.
The catheter is supplied sterile and non-pyrogenic. Different balloon sizes (5 mm to 10 mm) and catheter lengths (50 to 135 cm) are available. The proximal end of the catheter contains a hub with two female luer locks.
The device is compatible with 6-7F introducers. The introducer compatibility for each device size is listed on the device label itself. The materials used in the construction are biocompatible and latex free.
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K Number
K100169Device Name
DURASPAN HEMODIALYSIS LONG-TERM CATHETER
Manufacturer
R4 VASCULAR, INC.
Date Cleared
2010-02-18
(29 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
R4 VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The r4 Duraspan™ and the Duraspan™ Ultra long-term dialysis catheter is indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.
Device Description
The Duraspan™ Dialysis Catheter is designed for patients with End Stage Renal Disease needing chronic hemodialysis. The catheter is inserted percutaneously through the Subclavian or Jugular veins and placed in the venous system of the patient. Once in place, the catheters two proximal luer connectors are connected to a hemodialysis machine's blood lines. The machine's pump draws blood through the proximal lumen, indicated with the red connector, removing blood from the patient. The blood is processed in the hemodialysis filter or apheresis centrifuge. The blood is then returned through the lumen, marked by a blue connector, exiting out the most distal tip. The tip of the catheter is staggered to reduce recirculation of the blood.
The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Duraspan™ kit includes a catheter and introduction components. The catheter is supplied sterile.
The Duraspan 114 product line has catheters in a 15.5 Fr dual lumen. The catheters come in a variety of lengths (24-55cm) for patient specificity and access preference.
The Duraspan 104 is similar to the Duraspan ™ Ultra with a reduced tip stagger to address the variability of the dimensions of the vena cava in patients allowing for appropriate positioning of the arterial and venous lumens within the vena cava and right atrium.
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K Number
K091506Device Name
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
Manufacturer
R4 VASCULAR, INC.
Date Cleared
2010-01-08
(232 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
R4 VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The r4 Duraspan"10 long-term dialysis catheter is indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.
Device Description
The Duraspan™ Dialysis Catheter is designed for patients with End Stage Renal Disease needing chronic hemodialysis. The catheter is inserted percutaneously through the Subclavian or Jugular veins and placed in the venous system of the patient. Once in place, the catheters two proximal luer connectors are connected to a hemodialysis machine's blood lines. The machine's pump draws blood through the proximal lumen, indicated with the red connector, removing blood from the patient. The blood is processed in the hemodialysis filter or apheresis centrifuge. The blood is then returned through the lumen, marked by a blue connector, exiting out the most distal tip. The tip of the catheter is staggered to reduce recirculation of the blood.
The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Duraspan" kit includes a catheter and introduction components. The catheter is supplied sterile.
The Duraspan 114 product line has catheters in a 15.5 Fr dual lumen. The catheters come in a variety of lengths (24-55cm) for patient specificity and access preference.
The Duraspan 10 is similar to the Bard HemoGlide Star Series and the tip stagger is similar to the Arrow Step-Tip with the addition of a Biomimetic Coating that is identical to the coating on the Zeus Catheter.
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K Number
K092040Device Name
PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240
Manufacturer
R4 VASCULAR, INC.
Date Cleared
2009-11-18
(139 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
R4 VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The r4 Pherocious 14 apheresis triple lumen catheter is designed for short and long term (>30 days) apheresis, intravenous infusion, blood sampling and CECT via the jugular veins or subclavian vein. The maximum recommended flow rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.
Device Description
The r4 Vascular, Inc Pherocious™ is a family of apheresis triple lumen catheters designed to perform apheresis, intravenous infusion, blood sampling and power injection. The catheters, made of radiopaque polyurethane tubing are inserted via jugular, subclavian or femoral veins. Pherocious™ has a kink resistant, atraumatic, staggered tip design. The lumen with the purple connector, extension leg, and clamp may be used for CT injection as denoted by the text, "power injectable," printed on the extension leg. The remaining lumens with the red and blue connectors and blue and red or white clamps are for blood products. The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Pherocious™ kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic. The Pherocious 110 product line has catheters in 10.5 Fr and 12.5 Fr triple lumen. The catheters come in a variety of lengths for patient specificity. The Pherocious 10 is similar to Bard TriFusion with the addition of the ability to CECT inject that is substantially equivalent to the Zeus.
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K Number
K083763Device Name
ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
Manufacturer
R4 VASCULAR, INC.
Date Cleared
2009-03-16
(88 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
R4 VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zeus™ CT PICC is indicated for short or long-term (less than or greater than 30 days) peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.
Device Description
The r4 Vascular. Inc. Zeus™ CT PICC is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy, blood sampling, power injection of contrast media studies and central venous pressure monitoring. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each Zeus™ CT PICC has a kink resistant reverse tapered catheter design. The Zeus™ CT PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The Zeus™ CT PICC product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen.
The Zeus™ CT PICC is similar to HDC's V-Cath (Polyurethane) Power PICC (Power-V), with the addition of a Biomimetic Coating that is similar in performance to the Tyco Palindrome Emerald.
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K Number
K071361Device Name
R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005
Manufacturer
R4 VASCULAR, INC.
Date Cleared
2007-08-20
(97 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
R4 VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE R4 VASCULAR INC. PEGASUS CT PICC IS INDICATED FOR SHORT TERM AND LONG-TERM PERIPHERAL ACCESS TO THE CENTRAL VENOUS SYSTEM FOR INTRAVENOUS THERAPY AND POWER INJECTION OF CONTRAST MEDIA. FOR BLOOD SAMPLING, INFUSION, OR THERAPIES, USE A 4F OR LARGER CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 5F AND 6F PEGASUS CT PICC CATHETER MAY NOT EXCEED 300PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 5CC/SEC FOR 5F AND 6F CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 4F PEGASUS CT PICC CATHETER MAY NOT EXCEED 200PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 4CC/SEC FOR A 4F CATHETER.
Device Description
- The Pegasus CT PICC catheters are radiopaque polyurethane.
- Catheter usable length is 55 to 60 cm in length. It is available in a 4F/5F single lumen and 5F/6F dual lumen version.
- The catheter has a reverse taper design.
- Catheter lumen tubing is marked with depth markings for proper placement of the catheter during insertion.
- Catheters are provided sterile in basic radiology and nursing PICC configurations.
- The catheter has one power injectable lumen.
- Purple colorant was added to the catheter materials to distinguish it from other nono power injectable catheters and recognize it as a power injectable catheter.
- The catheter extension, ID rings are printed to identify the catheter as a Power Injectable Catheter to ensure proper use of the device.
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