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510(k) Data Aggregation
K Number
K150107Device Name
Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
Manufacturer
MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR
Date Cleared
2015-07-29
(190 days)
Product Code
DQY, DOY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Device Description
The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are designed for the introduction of interventional devices into the peripheral and neurovasculature. The Arc™ Mini are a single lumen, flexible, variable stiffness composite catheters with a Nitinol structure. A radiopaque marker band on the distal tip of the devices is used for visualization under fluoroscopy. The distal sections of both catheters are coated with a hydrophilic coating, which is used to reduce the overall frictional force during intravascular use. The Arc™ and Arc™ Mini dimensions are included in the individual device label. The devices are supplied sterile and are intended for single-use only.
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