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510(k) Data Aggregation
K Number
K965030Device Name
BRANNON ARTERIO-VENOUS PORTSYRINGE
Manufacturer
Date Cleared
1997-03-04
(77 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR LOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
fluid aspiration and subsequent transfer of whole blood to vacuum specimen tubes
Device Description
The piston syringe, made available in a 6cc size, of this 510(k) notification, known as the Brannon Arterio-Venous PortSyringe, A-VPS, is a combination of two legally marketed devices: (1) a piston syringe, and (2) a blood specimen collection device, BSCD. Additionally, the A-VPS is identical to the Brannon PortSyringe K960049, except the A-VPS includes a centrally disposed inner cannula within its barrel. The BSCD is integral with the plunger unit, with the BSCD communicating with the inner lumen of an attached indwelling catheter via the centrally disposed narrow conduit of the plunger and the centrally disposed inner-cannula within the barrel of the syringe. The fluid collection needle is sealed by a rubber sleeve.
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