OPTRELL Mapping Catheter with TRUEref Technology— 510(k) K230253

Substantially Equivalent

Biosense Webster, Inc.

FDA 510(k) clearance K230253 for OPTRELL Mapping Catheter with TRUEref Technology, Substantially Equivalent on 2023-03-02. Applicant: Biosense Webster, Inc..

Clearance details

Applicant: Biosense Webster, Inc.
Product code: Code MTD
Advisory panel: Cardiovascular
Date received: 2023-01-31
Decision date: 2023-03-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.