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510(k) Data Aggregation
K Number
K153685Device Name
Sunmed Haemostatic Valves
Manufacturer
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
Date Cleared
2016-10-13
(296 days)
Product Code
DQX, DTL
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SunmedTM Haemostatic Valves is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 Fr, 8 Fr or 9 Fr; The insertion tool facilitates introduction of guide wire through the haemostatic valves to reach the guiding catheter; The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.
Device Description
Hemostatic valves is composed of single Y connector, insertion tool and torquer. There are four models of the Hemostatic valves: Push-pull Y Connector, Screw Y Connector, Y click Connector and Double Screw Y Connector. Each single Y connector has two different structures: one is that the end of sideon is female luer; Another is that the end of sideon is the tubing and a stopcock. The Sunmed TM Hemostatic Valvesis designed to three external diameter of 7F, 8F, 9F for through different specifications of guide wire or catheter according to clinical need.
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