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Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100
FDA 510(k)Class II (US FDA 510(k))
510(k) K083623
Identifiers
- 510(k) Number
- K083623 FDA 510(k)
- FDA Product Code
- KRH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3800 FDA 510(k)
- Regulation Number
- 870.3800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100 by Edwards Lifesciences LLC — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083623 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K083623 24 fields · synced Jun 18, 2026