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510(k) Data Aggregation
K Number
K131079Device Name
CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
Manufacturer
Date Cleared
2013-08-01
(106 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
CREGANNA MEDICAL DEVICES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Creganna-Tactx Steerable Sheath Set is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Device Description
The Creganna-Tactx Steerable Sheath is a stainless steel braided steerable sheath which is compatible with EP Catheters ≤ 8.7Fr and has an approximate working length of 720mm. It is designed to provide flexible catheter positioning in the cardiac anatomy. The handle is equipped with a bi-directional rotating knob to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. There are two different models: The Symmetric Steerable Sheath has a tip that can be deflected into two distal curve geometries of equal symmetry, with reduced stroke in one direction; and the Asymmetric Steerable Sheath - one distal curve equal to the symmetric curve geometry above and a longer 'reach' curve geometry on the opposite curve to facilitate broader steering angles.
The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side-port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The steerable sheath features distal perfusion holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
The Creganna-Tactx Steerable Sheath is packaged as a set with the following accessories that are compatible with the dimensions of the steerable sheath: a polymer curved dilator (approximately 8.7 Fr), a 0.032" PTFE coated stainless steel J-tipped quidewire, and a guidewire J-straightener (introducer). The Set components are packaged together, provided sterile, and is intended for single use only.
The Creganna-Tactx Steerable Sheath Set assembly is comprised of materials that are commonly used in medical device applications.
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