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510(k) Data Aggregation
K Number
K141910Device Name
Intraosseous Cannula System Bio-MAC¿ and Bio-CORE
Manufacturer
Date Cleared
2015-05-04
(293 days)
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
BIOLOGIC THERAPIES INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Bio-MAC™ Bone Marrow Aspiration Cannula System is for use in the intraosseous aspiration of viscous bone marrow material in the human body.
The Bio-CORE™ Bone Marrow Biopsy Cannula System is for use in the intraosseous harvest and biopsy of "solid core" bone marrow material in the human body.
Device Description
The Bio-MAC™ Bone Marrow Aspiration Cannula System is an 11 gauge cannula needle system in various lengths (currently 25,45,60,80 and 105mm) that allows the use of a surgical drill "power driver" for hard bone insertion during a viscous bone marrow aspiration/collection procedure.
The Bio-CORE™ Bone Marrow Biopsy Cannula is an 11guage cannula needle system in various lengths (currently of 60, 80, and 105mm) that allows the use of a surgical drill "power driver" for hard bone insertion during a bone marrow solid core biopsy procedure.
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