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Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Cathe…
FDA 510(k)Class II (US FDA 510(k))
510(k) K221528
Identifiers
- 510(k) Number
- K221528 FDA 510(k)
- FDA Product Code
- DXF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5175 FDA 510(k)
- Regulation Number
- 870.5175 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Cathe… 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 | K221528 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K221528 24 fields · synced Jun 18, 2026