PeriCross Epicardial Access Kit
FDA 510(k) K243954 · Circa Scientific, Inc.
510(k) numberK243954
Submission
- Device name
- PeriCross Epicardial Access Kit
- Applicant
- Circa Scientific, Inc.
Englewood, CO, US - Received
- December 23, 2024
- Decision date
- April 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| 510(k) | Device | Decision |
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| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C…DXF · Special | 05/01/2025SE |
| K243193 | Cross Wise Multi-Use RF Adapter CableDXF · Special | 11/26/2024SE |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)…DXF · Traditional | 09/26/2024SE |
| K240004 | CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath…DYB · Special | 01/31/2024SE |
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | 05/25/2023SE |
| K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | 12/17/2021SE |
| K112376 | S-Cath Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | 08/31/2011SE |
Questions and answers
When was PeriCross Epicardial Access Kit cleared by the FDA?
PeriCross Epicardial Access Kit (K243954) received a 510(k) decision of Substantially Equivalent on April 24, 2025, 122 days after the submission was received.
What is the product code of K243954?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.