UNIRING - ANNULOPLASTY RING WITH SIZERS— 510(k) K071281

Name: FDA 510(k) clearance K071281
Creator: U.S. Food and Drug Administration
Published: 2007-08-03

Substantially Equivalent

Peters Surgical

FDA 510(k) clearance K071281 for UNIRING - ANNULOPLASTY RING WITH SIZERS, Substantially Equivalent on 2007-08-03. Applicant: Peters Surgical. Device class: 2.

Clearance details

Applicant: Peters Surgical
Product code: Code KRH
Device class: Class 2
Regulation: 21 CFR 870.3800
Advisory panel: Cardiovascular
Date received: 2007-05-07
Decision date: 2007-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bobigny, FR

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.