FDA.reportPublic FDA data

Aortic root retraction system

Definition
An assembly of devices intended to be used during aortic valve replacement via aortotomy to facilitate temporary stabilization of the aortic root for improved aortic valve site exposure, visualization and tissue tension. It consists of a circular frame that is placed within the aortic ring, sutures and suture retaining loops, and a deployment device with handle and shaft; it may be used during minimally-invasive and open surgery. This is a single-use device.
GUDID devices
16
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850012846291AVR NAVIGATOR™LSI Solutions, Inc.0814462024-02-02
00850012846307AVR NAVIGATOR™LSI Solutions, Inc.0814522024-02-02
00850012846314AVR NAVIGATOR™LSI Solutions, Inc.0814582024-02-02
00850200006551AORTIC ROOT RETRACTORLSI Solutions, Inc.0803002020-03-13
00850200006568AORTIC ROOT RETRACTORLSI Solutions, Inc.0802802020-03-13
00850200006575AORTIC ROOT RETRACTORLSI Solutions, Inc.0802602020-03-13
00858733006024MI CUFF - Aortic Root Exposure DeviceBiorep Technologies, Inc.4.02024-04-23
08022057015754CUFF Aortic Root Exposure DeviceCORCYM SRLMI-CUFF-0012026-02-03
18022057015751CUFF Aortic Root Exposure DeviceCORCYM SRLMI-CUFF-0012026-02-03
10858733006021MI CUFF - Aortic Root Exposure DeviceBiorep Technologies, Inc.4.02024-04-23
10850012846298AVR NAVIGATOR™LSI Solutions, Inc.0814462024-02-02
10850012846304AVR NAVIGATOR™LSI Solutions, Inc.0814522024-02-02
10850012846311AVR NAVIGATOR™LSI Solutions, Inc.0814582024-02-02
10850200006558AORTIC ROOT RETRACTORLSI Solutions, Inc.0803002020-03-13
10850200006565AORTIC ROOT RETRACTORLSI Solutions, Inc.0802802020-03-13
10850200006572AORTIC ROOT RETRACTORLSI Solutions, Inc.0802602020-03-13