Data / Medical devices / United States / CIRCA Scientific, Inc.
CIRCA Scientific, Inc.: FDA-registered device maker in Englewood, CO, United States, 9 510(k) clearances
CIRCA Scientific, Inc. is registered with the FDA (registration 3009437315) in Englewood, CO, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 1, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009437315
- Address
- 14 Inverness Dr E Ste H-136, Englewood, CO, United States, 80112
- Owner or operator
- CIRCA Scientific, Inc. (10038213)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 23, 2011
- Registered through
- 2026
- Brand names listed
- CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System, CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System, CardioCurve Steerable Sheath, CrossWise Multi-Use RF Adapter Cable, CrossWise RF Transseptal Access System, PeriCross Epicardial Access Kit, S-CATH Esophageal Temperature Probe and Temperature Monitoring System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Septostomy | DXF | 2 | Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2025 | K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | DXF | Substantially Equivalent | Circa Scientific, Inc. | accessdata.fda.gov |
| April 24, 2025 | K243954 | PeriCross Epicardial Access Kit | DYB | Substantially Equivalent | Circa Scientific, Inc. | accessdata.fda.gov |
| November 26, 2024 | K243193 | Cross Wise Multi-Use RF Adapter Cable | DXF | Substantially Equivalent | Circa Scientific, Inc. | accessdata.fda.gov |
| September 26, 2024 | K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) | DXF | Substantially Equivalent | Circa Scientific, Inc. | accessdata.fda.gov |
| January 31, 2024 | 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 | Substantially Equivalent | Circa Scientific, Inc. | accessdata.fda.gov |
| May 25, 2023 | K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System | FLL | Substantially Equivalent | Circa Scientific, Inc. | accessdata.fda.gov |
| December 17, 2021 | K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System | FLL | Substantially Equivalent | Circa Scientific, LLC | accessdata.fda.gov |
| July 23, 2021 | K210185 | CardioCurve Steerable Sheath | DYB | Substantially Equivalent | Talon Surgical | accessdata.fda.gov |
| August 31, 2011 | K112376 | S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM | FLL | Substantially Equivalent | Circa Scientific, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Cable, Electrode
- All makers of Introducer, Catheter
- All makers of Catheter, Septostomy
Updated May 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.