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Circa Scientific, Inc.

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

Total Devices6
Categories0
Latest FDA decision
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
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