DeviceClearance

K251007

Substantially Equivalent

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)

Applicant
Circa Scientific, Inc.
Product code
DXF
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Englewood, CO, US
Download summary PDF View on FDA.gov ↗

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, 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.