Penumbra System ACE 64 and ACE 68 Reperfusion Catheters

K152541NRY1/13/2016

Applicant

PENUMBRA, INC.

Intended Use

The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral — M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Indications for Use

The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral — M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Predicate Devices

  • K142458 - Penumbra System ACE 64 and ACE 68 Reperfusion Catheters (NRY)