ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606— 510(k) K965106

Name: FDA 510(k) clearance K965106
Creator: U.S. Food and Drug Administration
Published: 1998-01-27

Substantially Equivalent - Subject to Tracking & PMS

Biotronik, Inc.

FDA 510(k) clearance K965106 for ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606, Substantially Equivalent - Subject to Tracking & PMS on 1998-01-27. Applicant: Biotronik, Inc.. Device class: 3.

Clearance details

Applicant: Biotronik, Inc.
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 1996-12-20
Decision date: 1998-01-27
Decision: Substantially Equivalent - Subject to Tracking & PMS
Clearance type: Traditional
Location: Lake Oswego, OR, 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.