Company · US
Circa Scientific, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 2025 | K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) Circa Scientific, Inc. | DXF |
| Apr 24, 2025 | K243954 | PeriCross Epicardial Access Kit Circa Scientific, Inc. | DYB |
| Nov 26, 2024 | K243193 | Cross Wise Multi-Use RF Adapter Cable Circa Scientific, Inc. | DXF |
| Sep 26, 2024 | K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Mo Circa Scientific, Inc. | DXF |
| Jan 31, 2024 | K240004 | CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); C Circa Scientific, Inc. | DYB |
| May 25, 2023 | K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System Circa Scientific, Inc. | FLL |
| Dec 17, 2021 | K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System Circa Scientific, LLC | FLL |
| Aug 31, 2011 | K112376 | S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM Circa Scientific, LLC | FLL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||