Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable— 510(k) K232852

Substantially Equivalent

Cross Vascular, Inc.

FDA 510(k) clearance K232852 for Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable, Substantially Equivalent on 2023-10-12. Applicant: Cross Vascular, Inc..

Clearance details

Applicant: Cross Vascular, Inc.
Product code: Code DXF
Advisory panel: Cardiovascular
Date received: 2023-09-14
Decision date: 2023-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solana Beach, CA, 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, 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.