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510(k) Data Aggregation
K Number
K983039Device Name
EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF
Manufacturer
Date Cleared
1999-05-07
(249 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
SCHNEIDER/NAMIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature. The device also will deliver therapeutic solutions administered through the stopcock sidearm to the vasculature wall surrounding the sheath.
Device Description
The Emcee Infusion Introducer Sheath Set is comprised of a percutaneous introducer sheath and a dilator. The Emcee Infusion Introducer Sheath Set may also contain a guidewire. Design features have been added to the Emcee Introducer Set (K980504) to enhance the facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature. These design features include the addition of the dilator (from a point slightly distal to the dilator hub to a point proximal to the sheath tip). These design features permit a fluid ulfator nub to a point proximal to the space between the outer dilator wall and the inner sheath wall, and exiting into the vasculature lumen via the sheath sideholes.
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K Number
K980504Device Name
EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET
Manufacturer
Date Cleared
1998-08-07
(179 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
SCHNEIDER/NAMIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature (including the radial artery).
Device Description
The Emcee™ Introducer Set is comprised of a percutaneous introducer sheath and dilator. The set may also contain a guidewire and/or an obturator. The Emcee™ Introducer Sheath is comprised of an insert molded hemostatic sheath hub and cap design which encapsulates a hemostatic gasket system. The hub also incorporates a sideport extension line with an attached stopcock. The tubing portion of the sheath is percutaneously introduced into the patient's vasculature. The sideport extension is used for purposes of blood access maintenance and fluid administration. Subsequent to the physician gaining access to the patient's vasculature, a guidewire is inserted into the blood vessel. The Sheath/Dilator combination may be backloaded over the Guidewire to direct the device into the lumen of the vessel. Once the Sheath/Dilator assembly is in place, the dilator and Mini Guidewire (if used) are removed. The Emcee™ Dilator is a tapered plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Dilator is longer than the Sheath and with its tapered distal tip, serves to facilitate and support the entry of the Sheath into the patient's vasculature. Once the Emcee™ Introducer Sheath is in place, the Dilator is removed. The Emcee™ Introducer Set will be offered with dilators to accommodate the following guidewire diameters: .018", .025", .032", .035", and .038". Other sizes of dilators will also be provided to address physician preferences. The Emcee™ Obturator is a plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Obturator is approximately the same length as the Sheath and is intended to support the tubing portion of the Sheath while the device remains In Vivo. Components of the Emcee™ Introducer Set have a lubricious coating for a smooth entrance and removal from the vasculature.
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