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Volumeview System (Vlv520ft6r +2 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K100739
Identifiers
- 510(k) Number
- K100739 FDA 510(k)
- FDA Product Code
- KRB FDA 510(k)
- Models / Variants
- Vlv520ft6r FDA 510(k)Vlv520ft8r FDA 510(k)Vlv520ft6r5 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1915 FDA 510(k)
- Regulation Number
- 870.1915 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Volumeview System (Vlv520ft6r +2 more) by Edwards Lifesciences LLC — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS
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 | K100739 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K100739 24 fields · synced Jun 18, 2026