Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Circa Scientific, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories3
Latest FDA decision2025-05-01
TypeNumberDevice NameCodeDateActions
510(k) K251007 CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)DXF2025-05-01 View
510(k) K243954 PeriCross™ Epicardial Access KitDYB2025-04-24 View
510(k) K243193 Cross Wise™ Multi-Use RF Adapter CableDXF2024-11-26 View
510(k) K241414 CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)DXF2024-09-26 View
510(k) K240004 CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve SteerDYB2024-01-31 View
510(k) K222311 CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemFLL2023-05-25 View
↑