Advisor HD Grid X Mapping Catheter, Sensor Enabled— 510(k) K241372

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K241372 for Advisor HD Grid X Mapping Catheter, Sensor Enabled, Substantially Equivalent on 2024-07-09. Applicant: ABBOTT MEDICAL.

Clearance details

Applicant: ABBOTT MEDICAL
Product code: Code MTD
Advisory panel: Cardiovascular
Date received: 2024-05-15
Decision date: 2024-07-09
Decision: Substantially Equivalent
Clearance type: Special
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.