K071281

Substantially Equivalent

UNIRING - ANNULOPLASTY RING WITH SIZERS

Applicant: Peters Surgical
Product code: KRH
Advisory panel: Cardiovascular
Date received: 2007-05-07
Decision date: 2007-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bobigny, FR

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.