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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.