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. Device class: 1.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code DTJ
- Device class
- Class 1
- Regulation
- 21 CFR 870.3935
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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