MICARDIA ANNULOPLASTY BAND DR— 510(k) K070488

Substantially Equivalent

Micardia Corporation

FDA 510(k) clearance K070488 for MICARDIA ANNULOPLASTY BAND DR, Substantially Equivalent on 2008-09-04. Applicant: Micardia Corporation.

Clearance details

Applicant: Micardia Corporation
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 2007-02-20
Decision date: 2008-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.