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510(k) Data Aggregation
K Number
K212402Device Name
MIVI Q Distal Access Catheter
Manufacturer
MIVI Neuroscience, Inc.
Date Cleared
2021-12-16
(136 days)
Product Code
QJP, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MIVI Neuroscience, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MIVI Q Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
Device Description
The MIVI Q Distal Access Catheter (Q Catheter) is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. The proximal portion of the catheter is a stainless-steel control (push) wire. The Q Catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The Q Docking Station may be used to facilitate insertion and extraction of the Q Catheter through a hemostasis valve attached to the 8F guide catheter/6F guide sheath. The pin vise may be used to advance the catheter.
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K Number
K151825Device Name
Viradius Neurowire
Manufacturer
MIVI NEUROSCIENCE, INC.
Date Cleared
2015-11-16
(133 days)
Product Code
MOF, DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
MIVI NEUROSCIENCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viradius™ Neurowire is intended for selective placement of catheters within the neuro and peripheral vasculature.
Device Description
The Viradius™ Neurowire consists of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The distal section of the guidewire is coated with a hydrophilic coating and the proximal portion of the device is coated with a hydrophobic coating. The guidewire is inserted into a polyethylene hoop and then placed along with a torque device into a labeled poly/tyvek pouch and ethylene oxide sterilized. The pouch, along with an Instruction for Use paper insert is placed into a labeled shipping box.
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