510(k) K241414— CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)

Substantially Equivalent

Circa Scientific, Inc.

Clearance details

Applicant: Circa Scientific, Inc.
Product code: Code DXF
Advisory panel: Cardiovascular
Date received: 2024-05-17
Decision date: 2024-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Adverse events under product code DXF

product code DXF

Death: 78
Injury: 1,126
Malfunction: 507
Other: 1
Total: 1,712

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.