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C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET - 900500 1
FDA 510(k)Class II (US FDA 510(k))
510(k) K973378
Identifiers
- 510(k) Number
- K973378 FDA 510(k)
- FDA Product Code
- CAC FDA 510(k)
- Models / Variants
- 900500 1 FDA 510(k)At1 Autotransfusion Set Model 900 510 1 FDA 510(k)Psq Set (dd) Model 61 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5830 FDA 510(k)
- Regulation Number
- 868.5830 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET - 900500 1 by Fresenius Usa, Inc. — 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 | K973378 | Class II | Active |
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Manufacturer
- Manufacturer
- Fresenius Usa, Inc.
Sources (1)
- FDA 510(k) K973378 24 fields · synced Jun 18, 2026