LassoStar Circular Mapping Catheter— 510(k) K193632

Substantially Equivalent

Biosense Webster, Inc.

FDA 510(k) clearance K193632 for LassoStar Circular Mapping Catheter, Substantially Equivalent on 2020-06-30. Applicant: Biosense Webster, Inc..

Clearance details

Applicant: Biosense Webster, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2019-12-27
Decision date: 2020-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvin, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.