Circa Scientific, Inc.
Medical device manufacturer in Englewood, CO.
8510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C…DXF · Special | 05/01/2025SE |
| K243954 | PeriCross Epicardial Access KitDYB · Traditional | 04/24/2025SE |
| K243193 | Cross Wise Multi-Use RF Adapter CableDXF · Special | 11/26/2024SE |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)…DXF · Traditional | 09/26/2024SE |
| K240004 | CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath…DYB · Special | 01/31/2024SE |
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | 05/25/2023SE |
| K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | 12/17/2021SE |
| K112376 | S-Cath Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | 08/31/2011SE |