Navien Intracranial Support Catheter

K161152DQY10/12/2016

Applicant

MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR

Intended Use

The Navien™ Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Indications for Use

The Navien™ Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Predicate Devices

  • K110055 - Navien™ Intracranial Support Catheter (Originally cleared under trade name: ReFlex™ Guide Catheter) (DQY)