510(k) K153485

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

March 10, 2016

Date Received

December 3, 2015

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Temporary Carotid Catheter For Embolic Capture

Device Class

Class II

Regulation Number

870.1250

Review Panel

CV

Submission Type

This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i