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510(k) Data Aggregation
K Number
K021927Device Name
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
Manufacturer
BIOMET, INC.
Date Cleared
2002-07-12
(30 days)
Product Code
LXG
Regulation Number
862.2050Why did this record match?
Product Code :
LXG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Platelet Concentrate Separation kit is designed for use in the clinical laboratory or intra-operatively at point of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60 ml) of whole blood.
The plasma and concentrated platelets can be used for diagnostic tests.
Device Description
The platelet concentrate separation kit aids separation of the patient's own blood components by density through the use of a centrifuge. The platelet concentration kit permits platelet rich plasma to be rapidly prepared from a small volume of the patient blood that is drawn at the time of treatment.
Kit Components: 18 gauge x 1" x 12" apheresis needle, 16 gauge centesis needle 1 ¼" catheter, 60 ml piston syringe, 30 ml piston syringe, 1 ml piston syringe, petri dish, rubber tubing tourniquet, gauze pad, alcohol pad, adhesive tape, silicone tube, volume gauge, PETG tray with sealed Tyvek® lid
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