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510(k) Data Aggregation
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
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
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
K192684Device Name
HydroPearl Microspheres
Manufacturer
MicroVention, Inc.
Date Cleared
2020-01-22
(118 days)
Product Code
NOY, KRD, NAJ
Regulation Number
876.5550Why did this record match?
Applicant Name (Manufacturer) :
MicroVention, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HydroPearl® Microspheres are intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).
Device Description
The HydroPearl TM Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The HydroPearl TM Microspheres are offered in a variety of diameters ranging from 75-1100µm and are provided in a sterile syringe pre-filled with microspheres in phosphate buffered saline. The pre- filled syringe is packaged in a sealed sterile dispenser tray. The HydroPearl TM Microspheres are delivered to the treatment site through a delivery catheter.
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K Number
K192135Device Name
VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
Manufacturer
MicroVention, Inc.
Date Cleared
2019-12-24
(139 days)
Product Code
DQY, KRA
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MicroVention, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIA 21, 27, 33 - The VIA® Microcatheter is intended for the introduction of interventional devices (such as the WEB device/stents/flow diverters) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.
VIA 17, 17 Preshaped 45°, 17 Preshaped 90° - The VIA® Microcatheter is intended for the introduction of interventional devices (such as coils/stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.
Device Description
The VIA® Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the procedure the physician can obtain the position of the catheter by the radiopaque marker bands using fluoroscopic techniques (VIA17 Microcatheter has 2 radiopaque marker bands. VIA 21, 27 and 33 Microcatheters have one radiopaque tip marker band). Diagnostic and interventional devices can be delivered through the lumen of the catheter to the treatment site. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories.
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K Number
K192625Device Name
PG Pro Microcatheter
Manufacturer
MicroVention, Inc., A Terumo Group Company
Date Cleared
2019-11-21
(59 days)
Product Code
DQY, KRA
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MicroVention, Inc., A Terumo Group Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PG Pro microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.
Device Description
The PG Pro Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the catheter hub is used for the attachment of accessories.
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K Number
K173200Device Name
SOFIA Plus Aspiration Catheter
Manufacturer
MicroVention, Inc.
Date Cleared
2018-06-11
(252 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 SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment.
Device Description
The SOFIA Plus Aspiration Catheter is a single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to reduce friction during navigation in the vasculature. A luer fitting on the microcatheter hub is used for the attachment of accessories. The strain relief at the hub provides kink resistance for the proximal end. A steam shaping mandrel and introducer sheath are also packaged with the catheter. The SOFIA Plus Aspiration Catheter is used to remove thrombus/embolus from the neurovasculature using aspiration tubing and pump.
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