510(k) K231335

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

September 8, 2023

Date Received

May 8, 2023

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Adjunctive Epicardial Vascular Physiologic Status Indicator

Device Class

Class II

Regulation Number

870.2200

Review Panel

CV

Submission Type

The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not intended to quantify the degree to which epicardial disease is limiting flow through a vessel nor is it intended to independently direct therapy.