IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)— 510(k) K871596

Name: FDA 510(k) clearance K871596
Creator: U.S. Food and Drug Administration
Published: 1987-06-15

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K871596 for IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU), Substantially Equivalent on 1987-06-15. Applicant: Shiley, Inc.. Device class: 1.

Clearance details

Applicant: Shiley, Inc.
Product code: Code DTJ
Device class: Class 1
Regulation: 21 CFR 870.3935
Advisory panel: Cardiovascular
Date received: 1987-04-24
Decision date: 1987-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.