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The AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.

The AMPLATZER™ TorqVue™ 45°x45° 80 cm Delivery Sheath (TV45x45 80cm) is an extension of the AMPLATZERTM TorqVue 45x45 Delivery Sheath (TV45x45 100cm) product family (K120120 and K083214) and is available in both a 12Fr and 14Fr sheath size. The TV45x45 80cm is identical to the cleared TV45x45 (100cm) family of sheaths with the exception of having a shorter 80 cm length and the tip taper length of the 12Fr (80cm) dilator modeled on the taper length of the existing 14 Fr TV45x45 (100cm) dilator. The 80 cm length is consistent with several TorqVue Delivery System products including the TorqVue™ Delivery system (ITV) cleared under submission K072313 and the TorqVue™ (TVLA) delivery sheaths cleared under submission K120120. Similar to the predicate the TorqVue 45°x45° 80 cm Delivery Sheath includes a flush adapter, sheath and dilator. Figure 1 illustrates the delivery sheath and identifies the following essential components: Sheath (A) -Catheter that enables device delivery by the physician. The body of the sheath is radiopaque for visibility under fluoroscopy. For added visibility the sheath also has a radiopaque marker band near the distal tip. Dilator (B) -Used to ease penetration of tissue and minimize vessel trauma during sheath insertion into and through the vasculature. For added visibility the dilator is radiopaque for visibility under fluoroscopy. Flush Adaptor -The flush adaptor for both the 12F(C) and 14F (D) sheaths enables connection with syringes for flushing the sheath lumen.

The AMPLATZER™ TorqVue™ LP Catheter is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

The AMPLATZER TorqVue Low Profile Delivery Catheter (TVLPC) is an extension of the AMPLATZER TorqVue Low Profile Delivery System (TVLP) product line. The TVLPC is identical to the TVLP with the exception of a delivery wire, which is omitted on the TVLPC catheter only product. The TorqVue LP Catheter includes a catheter, loader, Tuohy-Borst hemostasis valve, and a self-sealing hemostasis valve. The TorqVue LP Catheter is intended for use with AMPLATZER devices packaged with a delivery wire. Figure 1 illustrates the delivery system and identifies the following essential components: Catheter – Single-lumen catheter that is used to deliver the device after it has . been positioned by the physician. The body of the catheter is radiopaque to increase visibility when using fluoroscopy. The distal end of the catheter is curved approximately 90°. Tuohy-Borst hemostasis valve – An adapter designed to control back-bleeding ● from the Delivery Catheter. . Loader - catheter short tube with luer fittings that aids in placing the desired devices into the Delivery Catheter. ● Self-sealing hemostasis valve - An adapter designed to control back-bleeding from the Delivery Catheter. The self-sealing valve provides additional sealing capabilities for use with delivery wires of smaller diameters.

The AMPLATZER® TorqVue FX Delivery System is intended to provide a pathway through which devices are introduced within the chambers of the heart.

The AMPLATZER® TorqVue® FX Delivery Systems (also referred to herein as ITV FX) are general purpose delivery systems designed to provide a pathway through which devices are introduced within the chambers of the heart. The ITV FX Delivery Systems are an extension of the AMPLATZER TorqVue (ITV) Delivery System product line. The technological characteristics of the ITV FX are the same as the predicate devices, with the following differences: The TorqVue FX Delivery System contains a flex . delivery cable assembly that incorporates a nitinol core wire surrounded by a stainless steel coil capped by a hub and a self-sealing hemostasis valve. The flex cable assembly provides rigidity for advancing devices through the sheath and allows the core wire to be extended out of the coil to provide flexibility for confirming correct placement of the deployed device. The Torq Vue FX Delivery System contains an 0.035" . compatible extension wire, which is only used for attaching to the delivery cable in vivo when there is a need to replace the sheath with a larger sheath. The standard ITV and ITV FX dilators fit over the extension wire and delivery cable core wire. The ITV FX Delivery System sheath will be offered with a 45° curve with a 60-cm useable length (6Fr, 7Fr, 8Fr) or 80-cm usable length (7Fr, 8Fr. 9Fr. 10Fr, 12Fr, 13Fr) and will be recommended for use with a subset of the AMPLATZER occluders that currently recommend the Torq Vue (45°) Delivery Systems. The ITV FX Delivery System includes a delivery sheath, dilator, delivery cable, extension wire, loader, delivery cable vise, two hemostasis valves, and for the 10, 12 and 13Fr products a flush adaptor to enable connection with syringes for flushing the sheath lumen. The sheaths are radiopaque for visibility under fluoroscopy.

The AMPLATZER TorqVue 45°x45°, LA1, and LA2 Delivery Sheaths are intended to provide a pathway through which devices are introduced within the chambers of the heart.

The AMPLATZER TorqVue LA and AMPLATZER TorqVue 45x45 Delivery Sheaths are general purpose delivery sheaths designed to access and deliver a device to the chambers of the heart. The TV45x45 Delivery Sheath is curved approximately 45° in two dimensions resulting in a three-dimensional geometry. The TVLA1 provides a single 45° curve on the distal end of the sheath. The TVLA2 provides the same 45° curve as the TVLA1 with a second superior curve at the distal tip of 20-30°. The sheaths are offered in five sizes each (9Fr, 10Fr, 12Fr, 13FR, and 14Fr). The TVLA sheaths and are 80 cm in length and the TV45x45 sheath is 100 cm in length. The devices include a sheath to enable device delivery, a dilator to ease entrance into and through the vasculature, and a flush adaptor for the 10, 12, 13, and 14Fr sizes to enable connection with syringes for flushing the sheath lumen. The sheaths and dilators are radiopaque for visibility under fluoroscopy. For added visibility, the sheaths also have a radiopaque marker band near the distal tip.