Sphere-9Dx Diagnostic Catheter (AFR-00009)— 510(k) K233433

Substantially Equivalent

Medtronic

FDA 510(k) clearance K233433 for Sphere-9Dx Diagnostic Catheter (AFR-00009), Substantially Equivalent on 2024-08-07. Applicant: Medtronic.

Clearance details

Applicant: Medtronic
Product code: Code MTD
Advisory panel: Cardiovascular
Date received: 2023-10-12
Decision date: 2024-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, 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.