MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF— 510(k) K933055

Substantially Equivalent - Subject to Tracking & PMS

Medtronic Vascular

FDA 510(k) clearance K933055 for MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF, Substantially Equivalent - Subject to Tracking & PMS on 1994-05-02. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1993-05-27
Decision date: 1994-05-02
Decision: Substantially Equivalent - Subject to Tracking & PMS
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTB

product code DTB

Death: 1,491
Injury: 67,311
Malfunction: 79,368
Other: 10
Total: 148,180

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.