CIRCA Scientific, Inc.
Englewood, CO, US
CIRCA Scientific, Inc. appears in FDA device records in Englewood, CO. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for CIRCA Scientific, Inc. between 2011 and 2025. The busiest year on record is 2024, with 3. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | DXF | Substantially Equivalent | |
| K243954 | PeriCross™ Epicardial Access Kit | DYB | Substantially Equivalent | |
| K243193 | Cross Wise™ Multi-Use RF Adapter Cable | DXF | Substantially Equivalent | |
| 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 | |
| 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 | |
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System | FLL | Substantially Equivalent | |
| K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System | FLL | Substantially Equivalent | |
| K112376 | S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM | FLL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009437315 | 3009437315 | CIRCA Scientific, Inc. | 14 Inverness Dr E Ste H-136, Englewood, CO 80112 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain