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510(k) Data Aggregation
K Number
K212324Device Name
RenovoCath
Manufacturer
RenovoRx, Inc.
Date Cleared
2021-08-23
(28 days)
Product Code
MJN
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
RenovoRx, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapentic agents, to selected sites in the peripheral vascular system. The RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vesses ranging between 3mm to 11mm in diameter.
The diagnostic and/or therapents are to be used in accordance with specifications outlined by the respective agent manufacturer.
Device Description
The RenovoCath is a multi-lumen, dual-balloon catheter with a two-part handle that is designed for targeted delivery of fluids, including radiopaque material and therapeutic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The effective length is 75cm to 85cm (adjustable). Radiopaque markers are located between the balloons to allow for identification of targeted site and position adjustment under fluoroscopic guidance. The RenovoCath is intended to be used with 6 Fr guide sheaths and 7 Fr guide catheters and is compatible with 0.014" guidewires.
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K Number
K191606Device Name
RenovoCath
Manufacturer
RenovoRx, Inc.
Date Cleared
2019-08-07
(51 days)
Product Code
MJN
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
RenovoRx, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vesses ranging between 3mm to 11mm in diameter.
The diagnostic and/or therapents are to be used in accordance with specifications outlined by the respective agent manufacturer.
Device Description
The RenovoCath is a multi-lumen, dual-balloon catheter with a two-part handle that is designed for targeted delivery of fluids, including radiopaque material and therapeutic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The effective length is 76cm to 86cm (adjustable). Radiopague markers are located between the balloons to allow for identification of targeted site and position adjustment under fluoroscopic guidance. The RenovoCath is intended to be used with 6 Fr guide sheaths and 7 Fr guide catheters and is compatible with 0.014" guidewires.
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K Number
K160067Device Name
RenovoCath
Manufacturer
RenovoRx, Inc.
Date Cleared
2017-03-07
(419 days)
Product Code
MJN, CAT
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
RenovoRx, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RenovoCath™ RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath™ RC120 is also indicated for temporary vessel occlusions including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath™ RC120 is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath™ RC120 is intended for use in arteries from 3mm in diameter for yessel entry and to occlude vessels ranging between 4mm to 11mm in diameter.
The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.
The RenovoCath™ RC120 Catheter is not intended for use in coronary and intracranial arteries.
The RenovoCath™ RC120 Catheter is not intended for embolic protection or as an aspiration catheter.
Device Description
The RenovoCath™ RC120 Catheter ("RenovoCath") is a multi-lumen, dual-balloon catheter. The distance between the proximal and distal balloons is adjustable. The RenovoCath is provided with two off-the-shelf 3cc syringes that facilitate precise inflation of the balloons under fluoroscopic guidance.
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K Number
K141175Device Name
RENOVOCATH RC120
Manufacturer
RENOVORX, INC.
Date Cleared
2014-10-24
(171 days)
Product Code
MJN, CAT
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
RENOVORX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RenovoCath™ RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath™ RC120 is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath™ RC120 is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 4mm to 11mm in diameter.
The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.
The RenovoCath™ RC120 Catheter is not intended for use in coronary and intracranial arteries.
The RenovoCath™ RC120 Catheter is not intended for embolic protection or as an aspiration catheter.
Device Description
The RenovoCath™ RC120 Catheter ("RenovoCath") is a multi-lumen, dual-balloon catheter. The RenovoCath is designed for targeted delivery of fluids, including diagnostic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The RenovoCath is provided with two off-the-shelf 3cc syringes that facilitate precise inflation of the balloons under fluoroscopic guidance.
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