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FDA 510(k), K101586, XTRA AUTOTRANSFUSION SYSTEM
FDA 510(k), K101586, XTRA AUTOTRANSFUSION SYSTEM
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510(K) Number: K101586
Device Name: XTRA AUTOTRANSFUSION SYSTEM
Manufacturer: SORIN GROUP ITALIA S.R.L.
Device Classification Name: apparatus, autotransfusion
Regulation Number: 868.5830
Classification Product Code: CAC
Date Received: 06/07/2010
Decision Date: 10/05/2010
Regulation Medical Specialty: Anesthesiology
Device Name: XTRA AUTOTRANSFUSION SYSTEM
Manufacturer: SORIN GROUP ITALIA S.R.L.
Device Classification Name: apparatus, autotransfusion
Regulation Number: 868.5830
Classification Product Code: CAC
Date Received: 06/07/2010
Decision Date: 10/05/2010
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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