PROSTHETIC RINGS #4400 MITRAL & 4500— 510(k) K831949

Name: FDA 510(k) clearance K831949
Creator: U.S. Food and Drug Administration
Published: 1983-07-29

Substantially Equivalent - Subject to Tracking & PMS

American Edwards Laboratories

FDA 510(k) clearance K831949 for PROSTHETIC RINGS #4400 MITRAL & 4500, Substantially Equivalent - Subject to Tracking & PMS on 1983-07-29. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code KRH
Device class: Class 2
Regulation: 21 CFR 870.3800
Advisory panel: Cardiovascular
Date received: 1983-06-16
Decision date: 1983-07-29
Decision: Substantially Equivalent - Subject to Tracking & PMS
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

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.