Circa Scientific, Inc.
FDA 510(k) & PMA Approved Devices — 6 products
Total Devices6
Categories3
Latest Approval2025-05-01
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | DXF | 2025-05-01 | View |
| 510(k) | K243954 | PeriCross Epicardial Access Kit | DYB | 2025-04-24 | View |
| 510(k) | K243193 | Cross Wise Multi-Use RF Adapter Cable | DXF | 2024-11-26 | 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) | DXF | 2024-09-26 | 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 Steer | DYB | 2024-01-31 | View |
| 510(k) | K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System | FLL | 2023-05-25 | View |
No matching devices.