MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST— 510(k) K914974

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K914974 for MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST, Substantially Equivalent on 1991-12-19. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1991-11-06
Decision date: 1991-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.