FDA 510(k) Applications Submitted by Circa Scientific, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240004 |
01/02/2024 |
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 Steerab |
CIRCA Scientific, Inc. |
| K243954 |
12/23/2024 |
PeriCrossÖ Epicardial Access Kit |
CIRCA Scientific, Inc. |
| K222311 |
08/01/2022 |
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System |
CIRCA Scientific, Inc. |
| K251007 |
04/01/2025 |
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) |
Circa Scientific, Inc. |
| K241414 |
05/17/2024 |
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) |
Circa Scientific, Inc. |
| K243193 |
09/30/2024 |
Cross WiseÖ Multi-Use RF Adapter Cable |
Circa Scientific, Inc. |
|
|
