Search Results
Found 1 results
510(k) Data Aggregation
K Number
K211893Device Name
SelectFlex Neurovascular Access System Family
Manufacturer
Q'Apel Medical Inc
Date Cleared
2021-08-05
(45 days)
Product Code
QJP, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Q'Apel Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Device Description
The SelectFlex Neurovascular Access System Family consists of sterile, single-use intravascular catheters used to facilitate access to target vasculature during interventional procedures. The system is composed of a SelectFlex Neurovascular Access Catheter, a 3cc Mode Control Syringe, a 7Fr Peel Away Introducer, Luer Activated Valve and a Dilator (only for versions with a Long Hydrophilic coating to ease dermal entry). The SelectFlex Neurovascular Access Catheter comes in usable lengths of 95, 105 or 115cm. The SelectFlex Neurovascular Access Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex Neurovascular Access Catheter comes in two options of a short hydrophilic coating length of 11.5cm or a long hydrophilic coating length of 30cm.
Ask a Question
Page 1 of 1