Circa Scientific, Inc. - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Circa Scientific, Inc. has 6 FDA 510(k) cleared medical devices. Based in Englewood, US.
Latest FDA clearance: May 2025. Active since 2023. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Circa Scientific, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by JW Regulatory Consulting, LLC as regulatory consultant.
6 devices
Cleared
May 01, 2025
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,...
Cardiovascular
30d
Cleared
Apr 24, 2025
PeriCross™ Epicardial Access Kit
Cardiovascular
122d
Cleared
Nov 26, 2024
Cross Wise™ Multi-Use RF Adapter Cable
Cardiovascular
57d
Cleared
Sep 26, 2024
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,...
Cardiovascular
132d
Cleared
Jan 31, 2024
CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S )
Cardiovascular
29d
Cleared
May 25, 2023
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
Cardiovascular
297d