Advisor HD Grid Mapping Catheter, Sensor Enabled— 510(k) K172393

Substantially Equivalent

St. Jude Medical, Inc.

FDA 510(k) clearance K172393 for Advisor HD Grid Mapping Catheter, Sensor Enabled, Substantially Equivalent on 2018-04-23. Applicant: St. Jude Medical, Inc..

Clearance details

Applicant: St. Jude Medical, Inc.
Product code: Code MTD
Advisory panel: Cardiovascular
Date received: 2017-08-08
Decision date: 2018-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, 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.