EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length

K180169•DQY•8/8/2018

Applicant

Imperative Care Inc.

Intended Use

The EagleRay Long Sheath and EagleRay Access Catheter are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Indications for Use

The EagleRay Long Sheath and EagleRay Access Catheter are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Predicate Devices

  • K111380 - Neuron Max System (DQY per 21 C.F.R. 870.1250)
  • K150107 - Arc & Arc Mini Intracranial Support Catheter (DQY per 21 C.F.R 870.1250)
  • K161152 - Navien Intracranial Support Catheter (DQY per 21 C.F.R 870.1250)