DeviceClearance

CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200— 510(k) K083470

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K083470 for CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200, Substantially Equivalent on 2009-01-23. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant
Edwards Lifesciences, LLC
Product code
Code KRH
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KRH

product code KRH
Death
45
Injury
2,235
Total
2,280

Source: openFDA MAUDE database, through . 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.