IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC— 510(k) K791732

Name: FDA 510(k) clearance K791732
Creator: U.S. Food and Drug Administration
Published: 1979-09-19

Substantially Equivalent

Oscor, Inc.

FDA 510(k) clearance K791732 for IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC, Substantially Equivalent on 1979-09-19. Applicant: Oscor, Inc.. Device class: 3.

Clearance details

Applicant: Oscor, Inc.
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 1979-09-05
Decision date: 1979-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harbor, FL, US

Download summary PDF View on FDA.gov ↗

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K031274 — MODEL 5071 MYOCARDIAL PACING LEAD2003-05-22
K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD2003-05-16

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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.