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QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR - Quadrox-I Small Adult Microporous Membrane Oxygenator
FDA 510(k)Class II (US FDA 510(k))
510(k) K093522
Identifiers
- 510(k) Number
- K093522 FDA 510(k)
- FDA Product Code
- DTZ FDA 510(k)
- Models / Variants
- Quadrox-I Small Adult Microporous Membrane Oxygenator FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4350 FDA 510(k)
- Regulation Number
- 870.4350 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR - Quadrox-I Small Adult Microporous Membrane Oxygenator by Maquet Cardiopulmonary AG — Class II…
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 | K093522 | Class II | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary AG
- FDA Applicant
- Maquet Cardiopulmonary, AG
Sources (1)
- FDA 510(k) K093522 24 fields · synced Jun 18, 2026