dec13e0b-28c9-4d80-9e53-46067422f1fbUpdatePublished32023-12-082022-07-29In Commercial Distribution00685447014591PrimaryGS1NRG RF Transseptal KitNTK-710-8590249225954Baylis Médicale Cie Inc11 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire falsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse47247Cardiac transseptal access setA collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.falseActiveDXFCatheter, SeptostomyDYBIntroducer, CatheterDevice Size Text, specify71cm Standard Curve C0 NRG Transseptal Needle; 8.5F 63cm TorFlex Transseptal Guiding Sheath with 90° curve; 230cm ProTrack Pigtail Wirefalsefalse