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510(k) Data Aggregation
K Number
K162253Device Name
Trapper Exchange Device
Manufacturer
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
Date Cleared
2017-01-06
(149 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Trapper Exchange Device is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. Trapper Exchange Device is not intended for use outside of the guide catheter.
Device Description
Boston Scientific Trapper" Exchange Device is an accessory device used to facilitate interventional device exchange while maintaining wire position in patients undergoing Percutaneous Coronary Intervention (PCI) procedures. Trapper" Exchange Device is a fixed wire catheter that has a balloon near the distal tip. The 10mm balloon is designed to secure a 0.014inch wire within a 6F to 8F guide catheter when inflated to 12atm. There is a 1mm radiopaque marker band in the tip and a 2mm marker band at the proximal edge of the balloon to facilitate its placement and identification during catheter exchanges. Trapper" Exchange Device has a single lumen luer hub for inflation and deflation of the balloon. The proximal shaft has markings with an adjustable stop for 90cm and 100cm guide catheter lengths to facilitate balloon placement. The proximal stop is pre-set for a 90cm guide.
Trapper" Exchange Device is designed for use with guide catheters having internal lumen diameters in the range of 6F (0.070inch or 1.7mm) to 8F (0.091inch or 2.3mm) and lengths ≥ 90cm. In 6F guide catheters the PCI catheter to be exchanged must have a shaft OD (Outer Diameter) ≤ 3.2F (0.043inch or 1.1mm).
The set is supplied as a single use sterile device.
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K Number
K152913Device Name
GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
Manufacturer
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
Date Cleared
2016-07-21
(293 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GORE® TIPS Set, GORE® TIPS Sheath and GORE® TIPS Needle, are intended to be used together for percutaneous transjugular liver access during diagnostic and interventional procedures in patients undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure.
Device Description
The GORE® TIPS Set consists of the GORE® TIPS Sheath and the GORE® TIPS Needle, which may be supplied together or individually.
GORE® TIPS Sheath: Transjugular Liver Access Introducer Sheath and Dilator:
The GORE® TIPS Sheath consists of a flexible introducer sheath with a hemostatic valve and a dilator. The introducer sheath includes an inner PTFE layer, a stainless steel coil and an outer jacket. The dilator has a tapered leading end and provides dilatation of the access vessel. The dilator hub has a direction indicator to allow identification of the leading end curvature direction. The dilator hub may be locked into place in the hub of the introducer sheath to prevent the dilator backing out of the sheath.
GORE® TIPS Needle: Transjugular Liver Access Needle and Guiding Catheter:
The GORE® TIPS Needle consists of a stainless steel hollow shaft and a guiding catheter. The needle handle has a direction indicator to allow identification of the leading end curvature direction. The guiding catheter has a tapered leading end and provides protection around the sharp needle tip during vascular access. A white needle status band printed on the trailing end of the needle shaft ensures correct positioning of the guiding catheter around the needle shaft when covering the sharp needle tip. The guiding catheter hub has a direction indicator that identifies the leading end curvature direction.
The set is supplied as a single use sterile device.
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