| 2025-05-01 |
K251007 |
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) |
DXF |
— |
— |
| 2025-04-24 |
K243954 |
PeriCross Epicardial Access Kit |
DYB |
Class II |
Cardiovascular |
| 2024-11-26 |
K243193 |
Cross Wise Multi-Use RF Adapter Cable |
DXF |
— |
— |
| 2024-09-26 |
K241414 |
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) |
DXF |
— |
— |
| 2024-01-31 |
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 |
Class II |
Cardiovascular |
| 2023-05-25 |
K222311 |
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System |
FLL |
Class II |
General Hospital |
| 2021-12-17 |
K200943 |
Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System |
FLL |
Class II |
General Hospital |