MODEL 4951M MYOCARDIAL UNIPOLAR LEAD— 510(k) K031210

Name: FDA 510(k) clearance K031210
Creator: U.S. Food and Drug Administration
Published: 2003-05-16

Substantially Equivalent

Metronic, Inc.

FDA 510(k) clearance K031210 for MODEL 4951M MYOCARDIAL UNIPOLAR LEAD, Substantially Equivalent on 2003-05-16. Applicant: Metronic, Inc.. Device class: 3.

Clearance details

Applicant: Metronic, Inc.
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 2003-04-17
Decision date: 2003-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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.