510(k) K050217— FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)

Substantially Equivalent

Biosense Webster, Inc.

Clearance details

Applicant: Biosense Webster, Inc.
Product code: Code MTD
Advisory panel: Cardiovascular
Date received: 2005-01-31
Decision date: 2005-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Diamond Bar, CA, US

Adverse events under product code MTD

product code MTD

Death: 22
Injury: 376
Malfunction: 986
Total: 1,384

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.