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Raptor Aspiration Catheter: The Raptor Aspiration Catheter with a compatible aspiration pump and Balt Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. Balt Aspiration Tubing Set: The Balt Aspiration Tubing Set is intended to connect the Raptor Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered in various sizes that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The distal tip of the catheter shaft includes a markerband and the proximal end of the catheter has a luer fitting to allow for the attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The Raptor Aspiration Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Raptor Aspiration Catheters are compatible with 0.014" – 0.018" guidewires. A peelable split Introducer Sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Raptor Aspiration Catheter into an appropriate vascular sheath. The catheter and Introducer Sheath are provided sterile, non-pyrogenic, and intended for single use only. The Balt Aspiration Tubing Set consists of one 100" HPF proximal tubing with a suction connector on one end and male rotator on the other, one 1-way Large Bore Stopcock, and one 10" HPF distal tubing with a female luer connector on one end and a male rotator on the other. The Balt Aspiration Tubing Set facilitates the supply of vacuum from a compatible aspiration pump to the distal tip of the Raptor Aspiration Catheter. Balt Aspiration Tubing Set is provided sterile, non-pyrogenic and it is intended for single use only.

The Zoom 7X Catheter, with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing, and the Zoom Aspiration Pump (or equivalent vacuum pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

The Zoom™ 7X Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the Zoom Aspiration Pump, using the Zoom Aspiration Tubing or the Zoom POD Aspiration Tubing. The Zoom 7X Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of the Zoom 7X Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy. The Zoom 7X Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices. The Zoom 7X Catheter is also packaged with two (2) introducer sheath accessories. The introducer is intended to assist with insertion of the Zoom 7X Catheter into the RHV or the guide catheter. The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom 7X Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing is made of common medical grade polymers.

The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible vacuum pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

The Aspiration Catheter, Delivery Catheter, and Base Camp Sheath comprise the Route 92 Medical HiPoint Reperfusion System. The Route 92 Medical HiPoint Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set and the Route 92 Medical Base Camp Sheath System. The Aspiration Catheter has a single-lumen, coil-reinforced polymer distal shaft section connected to a proximal control wire. The Delivery Catheter is a single-lumen variable stiffness catheter. Both catheters have hydrophilic coating. The devices are provided sterile and non-pyrogenic and are intended for single use only. The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter. For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set. The Route 92 Medical Base Camp Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8 French (F) or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.

The APRO 45 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Alembic Aspiration Tubing is intended to connect the APRO 45 Catheter to the aspiration pump.

The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 45 Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 45 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 45 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 45 Catheter is available in lengths of 115, 125, 146, and 160 cm and is provided with an introducer sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives. The Alembic Aspiration Tubing connects the APRO 45 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.

The APRO 55 Swift Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Alembic Aspiration Tubing is intended to connect the APRO 55 Swift Catheter to the aspiration pump.

The APRO 55 Swift Catheter is a single-lumen, braid and coil reinforced catheter designed to remove thrombus from the vasculature using aspiration. It targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature, guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation, and a radiopaque marker is at the distal end for fluoroscopic visualization. It is used with an aspiration pump connected via the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The catheter is available in lengths of 125 cm and 137 cm and is supplied with an introducer sheath. The Alembic Aspiration Tubing connects the APRO 55 Swift Catheter to the aspiration pump and features a flow control valve with an ON/OFF switch. It is available in a single size.

Millipede 070 Aspiration Catheter The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. Perfuze Aspiration Tube Set The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.

The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV). The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter. The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter. For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

The APRO 70 Swift Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Alembic Aspiration Tubing is intended to connect the APRO 70 Swift Catheter to the aspiration pump.

The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Swift Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Swift Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Swift Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Swift Catheter is available in lengths of 125 cm. 132 cm, and 135 cm and is provided with an introducer sheath. The Alembic Aspiration Tubing connects the APRO 70 Swift Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.

Penumbra Reperfusion Catheters and Separators As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. Penumbra 3D Revascularization Device As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. Penumbra Aspiration Tubing As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra System is comprised of the following devices: - Penumbra Reperfusion Catheter - . Penumbra 3D Revascularization Device - Penumbra Aspiration Pump - . Penumbra Aspiration Pump Canister/Tubing - Penumbra Aspiration Tubing - Penumbra Separator . The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature using aspiration. The Reperfusion Catheter delivers aspiration from the pump directly to the site of occlusion to remove the clot. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. Alternatively, a Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. The Penumbra Reperfusion Catheter is connected to the Penumbra Aspiration Pump using the Penumbra Aspiration Tubing and the Penumbra Aspiration Pump Canister. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel, rotating hemostasis valve (RHV), peelable sheath, and optionally, SENDit Technology (cleared under K191946). The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy.

The Zoom System, when used with the Zoom Aspiration Pump (or equivalent vacuum pump), is indicated for use in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

The Imperative Care Zoom System consists of the following devices: - Zoom Catheters - o Zoom™ (71, 55, 45, 35) Catheters - Large Distal Platform Catheters (LDP Catheters) ● - Zoom™ 88 Large Distal Platform™ (Zoom 88 LDP) o - Zoom™ 88 Large Distal Platform™ Support (Zoom 88 LDP Support) O - TracStar™ LDP Large Distal Platform™ (TracStar LDP) O - Zoom Aspiration Tubing and Zoom POD Aspiration Tubing - Zoom Aspiration Pump ● The Zoom Catheters and the LDP Catheters are intended to be used as a system in conjunction with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing and the Zoom Aspiration Pump (or equivalent vacuum pump) to aspirate thrombus in patients with acute ischemic stroke. The Zoom Catheters and LDP Catheters are single lumen, braid and coil reinforced, variable stiffness catheters with a radiopaque marker and a lubricious hydrophilic coating on the distal portion of the catheter. The catheters have a luer hub on the proximal end. Dimensions for each catheter are included on the individual device label. The Zoom Catheters are compatible with 0.014" - 0.018" guidewires. The LDP Catheters are compatible with 0.038" or smaller guidewires. An additional support catheter may be used to assist in accessing the target vasculature. The Zoom 45, 55, and 71 Catheters are compatible with 6F guide sheaths with a minimum inner diameter of 0.088". The Zoom 35 Catheter is compatible with 5F guide sheaths with a minimum inner diameter of 0.068". The LDP Catheters are compatible with 8F or greater introducer sheaths with a minimum inner diameter of 0.115". The Zoom 71 Catheter is compatible with 5F microcatheters or intermediate catheters with a maximum outer diameter of 0.065". The Zoom 45 and 55 Catheters are compatible with 2.4F microcatheters or intermediate catheters with a maximum outer diameter of 0.031". The Zoom 35 Catheter is compatible with 1.4F microcatheters or intermediate catheters with a maximum outer diameter of 0.018". The LDP Catheters are compatible with 6F microcatheters or intermediate catheters with a maximum outer diameter of 0.083". All catheters are packaged with an accessory rotating hemostasis valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices. The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing (Zoom POD) are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom Catheter and the LDP Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing and Zoom POD Aspiration Tubing are made of common medical grade polymers. In addition to the accessories discussed above, the adjunctive devices and supplies listed below could be used with the Zoom System. - Guidewires - Support/Diagnostic Catheters - Introducer Sheaths - Aspiration Pump* - Capable of achieving pressure between -20inHg to max vacuum (-29.9 inHg) - 0 Airflow rating of 0 23 LPM - 0 IEC 60601-1 Compliant * Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria.

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

The Riptide™ Aspiration System is designed to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries, using continuous aspiration. The Riptide™ Aspiration System is composed of the following components and illustrated in Figure 1: - 1. React™ 68 Catheter (REACT-68), React™ 71 Catheter (REACT-71, REACT-71-115, REACT-71-125) - 2. Riptide™ Large Bore Aspiration Tubing (MAT-110-110) - 3. Riptide™ Aspiration Pump (MAP-1000) - 4. Riptide™ Collection Canister with Intermediate Tubing (MAC-1200)