CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)— 510(k) K231412

Substantially Equivalent

Biosense Webster, Inc.

FDA 510(k) clearance K231412 for CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S), Substantially Equivalent on 2023-07-10. Applicant: Biosense Webster, Inc..

Clearance details

Applicant: Biosense Webster, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2023-05-16
Decision date: 2023-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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, 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.