510(k) K223809

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

May 30, 2023

Date Received

December 20, 2022

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Interventional Cardiovascular Implant Simulation Software Device

Device Class

Class II

Regulation Number

870.1405

Review Panel

CV

Submission Type

An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.