Search Results
Found 1 results
510(k) Data Aggregation
K Number
K042060Device Name
EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
Manufacturer
MILLIMED A/S
Date Cleared
2004-10-06
(68 days)
Product Code
DTL
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
MILLIMED A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EasyPass™ US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller.
The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter.
The torquer, when inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire.
Device Description
The EasyPass™ US Y-connector Hemostatic Valve consists of a y-connector body with a rotating luer lock, a sidearm and a hemostasis valve. To open the hemostasis valve, a valve opener cap with a center passage tube is pushed distally. The hemostasis valve is closed by pulling the valve opener cap proximally. The passage tube on the valve opener provides a completely opened and smooth lumen for the insertion of interventional devices.
Ask a Question
Page 1 of 1