EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR— 510(k) K880052
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K880052 for EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR, Substantially Equivalent on 1988-04-01. Applicant: Baxter Healthcare Corp.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code DTJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.