Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Adjunctive Epicardial Vascular Physiologic Status Indicator
510(k) Number K262839
Device Name Cleerly ISCHEMIA
Applicant
Cleerly, Inc.
1099 18th St., Suite 2860
Denver,  CO  80202
Applicant Contact Ivan Pulido
Correspondent
Cleerly, Inc.
1099 18th St., Suite 2860
Denver,  CO  80202
Correspondent Contact Ivan Pulido
Regulation Number870.2200
Classification Product Code
QXZ  
Date Received08/11/2026
Decision Date 10/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-