Circa Scientific, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F), PeriCross™ Epicardial Access Kit, Cross Wise™ Multi-Use RF Adapter Cable
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Circa Scientific, Inc. Cardiovascular ✕
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