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510(k) Data Aggregation
K Number
K241177Device Name
React 71 Catheter
Manufacturer
Micro Therapeutics lnc. d/b/a ev3 Neurovascular
Date Cleared
2024-05-28
(29 days)
Product Code
DQY, QJP
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Micro Therapeutics lnc. d/b/a ev3 Neurovascular
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Device Description
The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinumiridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ Coating.
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