NTE · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1250
Classification
FDA Product Code
NTE
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.1250
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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