K100709

Substantially Equivalent

EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M

Applicant: Edwards Lifesciences, LLC
Product code: DXG
Advisory panel: Cardiovascular
Date received: 2010-03-12
Decision date: 2010-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.