NRG RF Transseptal Kit

Device typeCardiac transseptal access set: A 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.

FDA categoryCatheter, Septostomy, Introducer, Catheter

Device ID00685447014874

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Size71cm Standard Curve C0 NRG Transseptal Needle; 8.5F 63cm TorFlex Transseptal Guiding Sheath with 45° curve