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The Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Needle is intended for single use only.

The Transseptal Sharp Needle consists of a stainless-steel needle and nitinol stylet. The needle comes in two lengths equivalent to the lengths of the TSN Transseptal Needle (predicate) - 71cm and 98cm, and two curves, Curve0 (59°) and Curve1 (72°). The size is 18 gauge with an inner diameter of .0325" at the proximal body and necks down to 21 gauge with an inner diameter of 0.0230" at the distal end with a sharp a-bevel offset tip. The transseptal sharp needle includes a 0.018" diameter nitinol stylet wire with an intermediate 0.013" section, a bulbous distal tip, and a proximal clear plastic handle with an internal mechanism configured to both provide feedback on the position of the stylet tip and as well as to maintain the stylet tip in the extended position to reduce the possibility for further penetration of the needle after the initial crossing of the septum. The components of the Transseptal Sharp Needle include the transseptal sharp needle, stylet. sterile packaqing, and labeling. There are four model numbers for the transseptal sharp needle: CLICK071, CLICK098, CLICK171, and CLICK198. The Transseptal Sharp Needle is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Sharp Needle is used in a healthcare facility/hospital. The transseptal sharp needle is used in transseptal procedures to puncture the fossa ovalis and gain access to the left atrium through the right side of the heart. The device is used by inserting the device through a transseptal dilator assembly. The devices are inserted in the femoral vein. The transeptal sharp needle is then advanced to the fossa ovalis. This mimics the procedure with the predicate device, TSN Transseptal Needle. Both the proposed device and the predicate device (K17950) have a needle point, made of stainless steel, have similar hub and handle, and have similar dimensions, design, and functionality. The needle's duration in the body is less than 24 hours.

SafeSept® is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.

The SafeSept® .018" Transseptal Guidewire is made of nitinol, a flexible memory wire material, device that is 140cm in length. The proximal end of the wire has 4 sets of laser-etched markings, which increase in quantity toward the proximal end of the wire. An echogenic marker was added along the shaft proximal to the radiopaque coil. A radiopaque coil located along the shaft, made of a platinum/tungsten alloy, aids in visual quidance during transseptal procedures. The sharp distal tip is able to perforate through the fossa ovalis, a thin wall separating the right and left interatrial septum, when it is supported by a transseptal needle and dilator. When the wire is no longer supported, it is atraumatic and operates as typical quidewire. The components of the SafeSept® include the .018" transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. The model number of the subject device is SS-140. The SafeSept® .018" Transseptal Guidewire is sterilized by 100% ethylene oxide cycle and is for single use-only. The subject device is used in transseptal procedures to gain access to the left atrium through the right side of the heart. The device is used by a surgeon by inserting the device through the femoral vein. The subject device is then advanced to the fossa ovalis with the support of the transseptal needle and dilator. The guidewire is used in conjunction with a transseptal needle and dilator. Its duration in the body is less than 24 hours. The SafeSept® .018" Transseptal Guidewire is used in a healthcare facility/hospital.