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510(k) Data Aggregation
K Number
K243638Device Name
MV Flow Aspiration Pump (MVFLOWPMP01)
Manufacturer
MicroVention
Date Cleared
2025-06-13
(200 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
MicroVention
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MV Flow Aspiration Pump is intended for general suction use in hospitals or clinics.
Device Description
The MV Flow Aspiration Pump is an electrically powered (100 VAC/50 Hz, 240 VAC/60 Hz) device designed to generate vacuum pressure and serve as the vacuum source intended for general suction use in hospitals or clinics. The MV Flow Aspiration Pump is not intended for use in transport or field settings. The pump delivers 29 inHg of maximum vacuum pressure with a maximum flow rate of 36 L/min. The power button and vacuum-relief button provide pressure control. The brushless DC, dual-diaphragm pump design includes reverse-flow protection. Compatible pump accessories, supplied separately, include the MV Flow Canister. The MV Flow Canister consists of a single-use collection canister with integrated bacteria filter, overflow protection, and a pre-installed intermediate tubing.
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K Number
K232542Device Name
Wedge XL Delivery Catheter
Manufacturer
MicroVention, Inc.
Date Cleared
2024-05-16
(268 days)
Product Code
QJP
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MicroVention, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wedge XL Delivery Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.
Device Description
The Wedge XL Delivery Catheter is a single lumen catheter designed to be introduced over a steerable quidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Radiopaque markers at the distal end facilitate fluoroscopic visualization. A larger diameter distal segment helps provide stability for navigation. The distal 110 cm outer surface of the Wedge XL Delivery Catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Wedge XL Delivery Catheter hub is used for the attachment of accessories.
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K Number
K230775Device Name
SOFIA EX Intracranial Support Catheter
Manufacturer
MicroVention, Inc.
Date Cleared
2023-09-14
(177 days)
Product Code
QJP, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MicroVention, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SOFIA EX Intracranial Support Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA EX Intracranial Support Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA EX Intracranial Support Catheter is not intended for use in coronary arteries.
Device Description
The SOFIA™ EX Intracranial Support Catheter is a single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm of distal shaft hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (polyethylene) that is provided in a sterile barrier Tyvek pouch and placed in a carton box.
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K Number
K222694Device Name
EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
Manufacturer
MicroVention, Inc.
Date Cleared
2023-04-27
(233 days)
Product Code
NTE
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MicroVention, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EmPro™ EPS/Nanoparasol™ EPS is indicated for use as a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the filter placement should be between 3.0 and 6.5 mm.
Device Description
MicroVention's Embolic Protection System (EPS) is marketed under two names: EmPro™ Embolic Protection System and Nanoparasol™ Embolic Protection System. The Embolic Protection System (EPS) is designed to capture and remove dislodged debris during a carotid interventional procedure. It consists of three basic components and additional accessories:
1) An Embolic Protection Device (EPD) consisting of a nitinol braided mesh filter with an atraumatic distal tip built on an integrated .014" PTFE coated stainless steel capture delivery wire.
2) A 3.5F delivery catheter with 150 cm length.
3) A 5F retrieval catheter with 150 cm working length. Accessories include a wire introducer, EPD loading cover, sheath introducer and a torque device. Catheters are provided in two separate dispenser coils.
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K Number
K222115Device Name
ISAAC Neurovascular Navigation Catheter
Manufacturer
MicroVention, Inc.
Date Cleared
2023-01-10
(176 days)
Product Code
DQY, QJP
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MicroVention, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ISAAC™ Neurovascular Navigation Catheter is indicated for use in facilitating advancement of catheters through the neuro and peripheral vasculature and introduction of diagnostic agents. The ISAAC™ Neurovascular Navigation Catheter is not intended for use in the coronary vasculature.
Device Description
The ISAAC™ Neurovascular Navigation Catheter) is a braid-reinforced variable stiffness catheter with a pre-shaped distal segment. The distal end of the catheter is coated with a hydrophilic coating around the curve of the pre-shaped section of the Simmons (SIM) configuration. It is a single lumen catheter with a radiopaque distal coiled section and a Luer hub on the proximal end. The ISAAC Catheter is sterile, non-pyrogenic and intended for single use only.
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K Number
K223050Device Name
AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
Manufacturer
MicroVention Inc.
Date Cleared
2022-12-21
(83 days)
Product Code
KRD
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
MicroVention Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AZUR system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, atteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
Device Description
The Detachable AZUR HydroPack 18 Peripheral Coil System with a controlled detachable delivery method consists of an implantable coil, a delivery pusher, and a Detachment Controller (sold separately). The implantable coils are made of platinum alloy with a hydrogel inner core. The coil is attached to the delivery pusher via a polyolefin elastomer filament. The coil implant is delivered to the target treatment site through a microcatheter which has an inner dimension that is compatible with the selected AZUR HydroPack 18 Peripheral Coil System. The proximal end of the delivery pusher is inserted into the hand-held battery powered AZUR Detachment Controller. When the implantable coil has been successfully placed in the desired location, the AZUR Detachment Controller is activated and a flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implantable coil. The AZUR Detachment Controller is packaged and sold separately.
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K Number
K214024Device Name
SOFIA 88 Catheter
Manufacturer
MicroVention, Inc.
Date Cleared
2022-09-12
(264 days)
Product Code
DQY, QJP
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MicroVention, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SOFIA 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA 88 Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA 88 Catheter is not intended for use in coronary arteries.
Device Description
The SOFIA 88 Catheter is a non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal seqment is designed to facilitate vessel selection with 60 cm of distal-shaft hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.
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K Number
K211120Device Name
ERIC Retrieval Device
Manufacturer
MicroVention Inc.
Date Cleared
2022-03-31
(350 days)
Product Code
NRY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MicroVention Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ERIC Retrieval Device is indicated to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Device Description
The ERIC™ (Embolus Retriever with Interlinked Cage) Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by removing clots from vasculature in patients suffering from acute ischemic stroke. The device consists of retrieval spheres secured on a pusher wire that are designed to capture and remove blood clots from the neurovasculature. The device is inserted into a microcatheter to navigate to the target location and retrieve the thrombus while the device is withdrawn from the vessel.
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K Number
K193607Device Name
BOBBY Balloon Guide Catheter
Manufacturer
MicroVention, Inc.
Date Cleared
2020-07-21
(208 days)
Product Code
DQY, QJP
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MicroVention, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BOBBY Balloon Guide Catheter is intended: For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
Device Description
The BOBBY Balloon Guide Catheter is a co-axial, braid-reinforced, variable stiffness catheter with an external hydrophilic coating. The BOBBY Balloon Guide Catheter incorporates a compliant balloon, radiopaque markers, and a bifurcated luer hub on the proximal end. The BOBBY Balloon Guide Catheter has an inner lumen through which a guidewire and catheter can be inserted, and a co-axial outer lumen that is used to inflate and deflate the balloon with a syringe filled with contrast media. A bifurcated luer hub is attached to the proximal end of the balloon guide catheter to provide access to both the inner and outer lumens. In addition, a hydrophilic coating is applied to the distal end of the balloon guide catheter to provide a lubricious outer surface for catheter advancement in the vasculature. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The balloon incorporates a distal air-purging system to purge air from the inflation lumen prior to use. The balloon catheter also incorporates radiopaque markers to facilitate fluoroscopic visualization and indication of the balloon position.
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K Number
K200547Device Name
Traxcess 14 SELECT Guidewire
Manufacturer
MicroVention Inc.
Date Cleared
2020-04-16
(44 days)
Product Code
MOF, DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
MicroVention Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Traxcess™ 14 SELECT Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
Device Description
The Traxcess™ 14 SELECT Guidewire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. The core wire proximal coated section is 0.014" stainless steel wire, and the distal coated section is tapered nitinol wire, contained within a 0.012" outer diameter wire coil. The wire coil is 400 mm in length. The distal 30 mm coil section is constructed of platinum/nickel for maximum radiopacity, and the balance, 370mm of the coil is constructed of stainless steel. The distal 14 mm section of the guidewire is shapeable by the physician. The coil section of the guidewire and the distal stainless-steel section is coated with a hydrophilic coating, while the proximal stainless-steel section is coated with PTFE. The purpose of these surface coatings is to provide lubricity when the Traxcess™ 14 SELECT guidewire is passed through percutaneous catheters. A shaping mandrel, torque device, and insertion tool are included with the device.
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