510(k) K231335
K231335 is an FDA 510(k) premarket notification submitted by Cleerly, Inc. for the device "Cleerly ISCHEMIA". The FDA issued a decision of Substantially Equivalent on September 8, 2023. The device falls under product code QXZ (Adjunctive Epicardial Vascular Physiologic Status Indicator), a Class II device regulated under 21 CFR 870.2200. Cleerly, Inc. has at least 3 other 510(k) clearances on record.
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.