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The VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System and VentiV Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

The VentiV Mechanical Thrombectomy System devices are single-use, sterile, short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The System includes (1) VentiV Mechanical Aspirator and (1) VentiV 7Fr - 12Fr catheters and dilators.

The Aspire Aspirator G is a piston syringe to inject fluids into, or aspirate fluids from, the body.

The Subject Device is a single-use, hand-held, and general-purpose aspirator configured with a barrel, plunger, and handles. The front handle is pivotally connected the back handle and distally connected to the barrel. The back handle is pivotally connected to the front handle and distally connected to the plunger. Squeezing the handles creates a mechanical advantage to move the plunger inside the barrel. The handle design also prevents the plunger from being pulled completely out of the barrel during use. The main difference between the Subject Device and the Predicate is the addition of a basic off-the-shelf pressure gauge and change from a one-piece to two-piece button between the handles.

The Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspirator is indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

The Subject Device includes (1) Aspire Aspirator and (1) MAX 7F - 11F Catheter. Subject Device and the Predicate are single-use, sterile, and short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The Subject Device's Intended Use and Fundamental Scientific Principle are the same as the Predicate. The Predicate and Subject Device are the same in the way they are inserted into the body over a guidewire and advanced to the target arterial or venous peripheral vascular anatomy. The Subject Device and Predicate share the same core Aspirator to create thrombectomy force. MAX 7 - 11F Catheters may be connected to basic syringes and other aspiration pumps. Aspire Mechanical Aspirators may be connected to other catheters. The Subject Device does not add any new materials or manufacturing processes to the manufacturing process.

The Aspire RX-LP6 Aspiration Catheter and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

An "Aspire RX-LP6 Aspiration Catheter" includes (1) RX-LP6 Aspiration Catheter and (1) Aspire Aspirator 30ml. - Aspire RX-LP6 Aspiration Catheters (RX-LP6 Aspiration Catheter and Aspire Aspirator): 6F -Guide Cath compatible rapid exchange catheter with 4.8mm long distal aspiration opening, 1.0mm wide distal and 1.1mm wide proximal aspiration lumen, 0.054" outer diameter (OD) single lumen aspiration shaft, and removable stylet. - Aspire Aspirator 30ml. - Aspire RX-LP6 Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with piston syringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire RX-LP6 Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A syringe is then connected to the catheter and the aspiration is manually created with the syringe. Similar to predicate devices, industry standard intravascular catheter components and materials are used: - -Clear proximal polycarbonate female luer lock, - Stainless steel core wire. - - Clear Main Shafts, - - Embedded platinum iridium radiopaque marker, - - Clear polycarbonate barrel piston syringe. - Aspire RX-LP6 Aspiration Catheters do not add any new materials, or manufacturing processes to the manufacturing process. Same as predicates, all RX-LP6 Aspiration Catheters may be connected to piston syringes including the Aspire Mechanical Aspirator. Aspirators may be connected to other catheters to aspirate fluids and thrombus.

The Aspire MAX 5 and MAX 6 Aspiration Catheters and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

An Aspire MAX Aspiration Catheter includes (1) Aspire MAX 6 Aspiration Catheter and (1) Aspirator 30ml. Aspire MAX Aspiration Catheters and MAX Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with manually operated piston syringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire MAX Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A piston syringe is then connected to the catheter and the aspiration is manually created with the piston syringe. Similar to predicate devices, industry standard intravascular catheter components and materials are used: - Clear proximal polycarbonate female luer lock, - -Stainless steel braid, - Clear Pebax and Vestamid Shafts, - - -Embedded platinum iridium radiopaque marker, - Clear polycarbonate barrel piston syringe. - Aspire MAX Aspiration Catheters do not add any new materials, manufacturing processes, colorants, or dyes to the manufacturing process. Same as predicates, all MAX Aspiration Catheters may be connected to piston syringes including the Aspire Aspirator. Aspirators may be connected to other aspiration catheters.