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510(k) Data Aggregation
K Number
K251189Device Name
Aventus Thrombectomy System
Manufacturer
Inquis Medical
Date Cleared
2025-06-13
(57 days)
Product Code
QEW
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
Inquis Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aventus Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Aventus Thrombectomy System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
Device Description
The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for the minimally invasive removal of emboli and thrombi from blood vessels, infusing fluids, and is intended to be used in the peripheral vasculature and for the treatment of pulmonary embolism. The System is comprised of the following major components:
- Aventus Thrombectomy Catheter
- Clot Management System consisting of:
- Aspiration Syringe
- Clot Canister
The System is compatible with a standard 24-French (24F) introducer sheath, 4F Navigation Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and includes a Sensing Indicator and houses the Sensing electronics. The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.
The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.
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K Number
K250668Device Name
Aventus Thrombectomy System (IM-2100)
Manufacturer
Inquis Medical
Date Cleared
2025-03-25
(20 days)
Product Code
QEW, KRA, OEW, REQ
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
Inquis Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aventus Thrombectomy System is indicated for:
• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Aventus Thrombectomy System is intended for use in the peripheral vasculature.
Device Description
The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:
- Aventus Thrombectomy Catheter .
- Clot Management System consisting of:
- . Aspiration Syringe
- . Clot Canister
The System is compatible with standard introducer sheaths (24F or 16F). 4F or 5F Navigation Catheters (based on Aventus Thrombectomy Catheter model), and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and includes a Sensing Indicator and houses the Sensing electronics.
The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.
The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.
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K Number
K250202Device Name
Aventus Thrombectomy System
Manufacturer
Inquis Medical
Date Cleared
2025-02-26
(33 days)
Product Code
QEW, OEW, REQ
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
Inquis Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aventus Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels.
- Iniection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Aventus Thrombectomy System is intended for use in the peripheral vasculature.
Device Description
The Aventus Thrombectomy System is a catheter-based manual aspiration svstem designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:
- Aventus Thrombectomy Catheter
- Clot Management System consisting of:
- Aspiration Syringe
- Clot Canister
The System is compatible with a standard 24-French (24F) introducer sheath, 4F or 5F Navigation Catheters (based on Aventus Thrombectomy Catheter model) and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and includes a Sensing Indicator and houses the Sensing electronics.
The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.
The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.
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K Number
K240426Device Name
Aventus Clot Management System
Manufacturer
Inquis Medical
Date Cleared
2024-05-14
(91 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
Inquis Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aventus Clot Management System is indicated for use with the Aventus Thrombectomy System for autologous blood transfusion.
Device Description
The Aventus Clot Management System accessory allows for autologous injection of aspirated blood from the Aventus Thrombectomy System embolectomy procedure. The sterile, single-use Aventus Clot Management System is comprised of the following two components:
- Aspiration Syringe
- . Clot Canister
The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.
The Clot Canister connects to the Aspiration Syringe via quick disconnect connector at the inlet port on the side of the Canister. The aspirant from the Aventus Thrombectomy System procedure is injected into the Clot Canister. The blood passes through the Clot Canister dual layer nominal 40u/200u polyester screen filter, filling a syringe pre-connected to the female luer lock that is positioned below the filter assembly. The clinician can then return the filtered blood back to the patient via a standard sterile syringe with a required suitable blood transfusion filter (not provided).
The Clot Canister also has a flush port with a standard 3-way stopcock positioned above the filter assembly where an additional syringe can be attached to inject saline or air to assist in clot visualization without removing the lid.
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K Number
K240117Device Name
Aventus Thrombectomy System (IM-2001/IM-0002)
Manufacturer
Inquis Medical
Date Cleared
2024-03-15
(59 days)
Product Code
QEW, KRA
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
Inquis Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aventus Thrombectomy System is indicated for:
· The non-surgical removal of emboli and thrombi from blood vessels.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Aventus Thrombectomy System is intended for use in the peripheral vasculature.
Device Description
The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:
- Aventus Aspiration Catheter II .
- . Clot Management System consisting of:
- . Aspiration Syringe
- . Clot Canister
The System is compatible with a standard 24-French (24F) introducer sheath, 4-French (4F) Support Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
The Aventus Aspiration Catheter II includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. A dedicated navigation catheter lumen for use with an off-the-shelf 4F Navigation Catheter, and dedicated infusion lumen for injection of fluids is also included in the shaft. The Catheter Handle assists the clinician in navigating within the vasculature and also includes a Sensing Indicator and houses the Sensing electronics. The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.
The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.
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K Number
K232730Device Name
Aventus Thrombectomy System
Manufacturer
Inquis Medical
Date Cleared
2023-11-01
(55 days)
Product Code
QEW, KRA, REG
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
Inquis Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aventus Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Aventus Thrombectomy System is intended for use in the peripheral vasculature.
Device Description
The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:
- Aspiration Catheter
- Clot Management System consisting of:
- Aspiration Syringe
- Clot Canister
The System is compatible with a standard 24-French (24F) introducer sheath, 4-French (4F) Support Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
The Aspiration Catheter includes an atraumatic radiopaque Distal Tip with angled aspiration orifice for directional aspiration and navigation without a dilator, a dedicated navigation catheter lumen with integrated Navigation Catheter, a dedicated infusion lumen for injection of fluids, and a Handle designed to navigate within the vasculature. The Aspiration Catheter shaft incorporates a metallic reinforcement made of stainless steel, an inner liner and polymeric jacket material with variable stiffness.
The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.
Ask a Question
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