IMPLANTABLE ENDOCARDIAL PACING LEADS— 510(k) K831926

Name: FDA 510(k) clearance K831926
Creator: U.S. Food and Drug Administration
Published: 1984-03-12

Substantially Equivalent

Oscor, Inc.

FDA 510(k) clearance K831926 for IMPLANTABLE ENDOCARDIAL PACING LEADS, Substantially Equivalent on 1984-03-12. Applicant: Oscor, Inc.. Device class: 1.

Clearance details

Applicant: Oscor, Inc.
Product code: Code DTG
Device class: Class 1
Regulation: 21 CFR 870.3690
Advisory panel: Cardiovascular
Date received: 1983-06-15
Decision date: 1984-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harbor, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.