PeriCross Epicardial Access Kit— 510(k) K243954
Substantially EquivalentCirca Scientific, Inc.
FDA 510(k) clearance K243954 for PeriCross Epicardial Access Kit, Substantially Equivalent on 2025-04-24. Applicant: Circa Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Circa Scientific, Inc.
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
Recent devices under product code DYB
view allMore clearances from Circa Scientific, Inc.
view all- K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
- K243193 — Cross Wise Multi-Use RF Adapter Cable
- K241414 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C) +1 more
- K240004 — CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ) +7 more
- K222311 — CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.