> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Class 2 for Embolic Protection Temporary Catheter
- URL: https://www.fdaweb.com/class-2-for-embolic-protection-temporary-catheter/
- Published: 2018-01-30T12:00:00.000Z
- Updated: 2026-09-14T23:18:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140636

*Federal Register* notice: FDA has classified the temporary catheter for embolic protection during transcatheter intracardiac procedures into Class 2 (special controls). The action is in response to a 9/2016 de novo classification request by Claret Medical for its Sentinel Cerebral Protection System. The agency has identified the generic type as a single-use percutaneous catheter system that has a blood filter at the distal end. This device is indicated for use while performing transcatheter intracardiac procedures, and it is used to filter blood in a manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure traveling toward the cerebral circulation. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-01-30/pdf/2018-01638.pdf?ref=fdaweb.com).