NTE

36 FDA 510(k) clearances · Product code

FDA profile

Official device name

Temporary Carotid Catheter For Embolic Capture

Device class

Class II (moderate risk)

Regulation

21 CFR 870.1250

Medical specialty

Cardiovascular

FDA 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

Adverse events (MAUDE)

2021: 327 · 2022: 326 · 2023: 354 · 2024: 398 · 2025: 410 · 2026: 210
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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