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The Ruby XL System is indicated for arterial and venous embolizations in the peripheral vasculature.

The Ruby XL System is comprised of a platinum embolization coil attached to a composite delivery pusher, and the Penumbra Detachment Handle. The coil/delivery pusher is packaged separately from the Penumbra Detachment Handle.

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 Access25 Delivery Microcatheter is indicated to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.

The Access25 Delivery Microcatheter (Access25) is a single lumen medical device designed to aid a physician in accessing distal vasculature when used in conjunction with a guide catheter and micro guidewire. The Access25 Delivery Microcatheter is supplied with annealed stainless steel mandrels that can be used to shape the distal tip as desired.

The Element Vascular Access System is indicated for the introduction of therapeutic or diagnostic devices into the vasculature.

The Element Vascular Access System is a medical device system designed to provide a conduit for introduction of therapeutic devices to the peripheral, coronary, and neurovascular anatomy. This device is a three-component system comprised of the BMX81 Delivery Catheter, Penumbra (Neuron 5F) Select Catheter, and a Dilator. The BMX81 Delivery Catheter can be used individually with a 0.038 in [0.97 mm] guidewire or together with the Neuron 5F Select Catheter to access the desired anatomy. The sheath component of the device contains an inner diameter of 6 French (Fr) and lengths ranging from 55 - 115 centimeters (cm).

INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The INDIGO® Aspiration System is comprised of several devices: - INDIGO Aspiration Catheter - Penumbra Aspiration Pump - INDIGO Aspiration Pump Canister - INDIGO Aspiration Tubing - INDIGO Separator The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The Lightning Bolt Aspiration Tubing (INDIGO Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating transfer of vacuum between the Penumbra Aspiration Pump and the INDIGO Aspiration Catheter while providing intermittent, continuous, or modulated aspiration. Modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the INDIGO Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous (IV) bag at ambient pressure.

INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The INDIGO® Aspiration System is comprised of the several devices: INDIGO Aspiration Catheter, Penumbra Aspiration Pump, INDIGO Aspiration Pump Canister, INDIGO Aspiration Tubing, INDIGO Separator. The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. TraX may be used with its prepackaged Aspiration Catheter to facilitate access to the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, Select Catheter, introducer, and TraX. TraX compatibility is limited to its prepackaged Aspiration Catheter. The INDIGO Separator may be provided with an introducer and torque device.

INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.

The INDIGO® Aspiration System is comprised of the several devices: INDIGO Aspiration Catheter, Penumbra Aspiration Pump, INDIGO Aspiration Pump Canister, INDIGO Aspiration Tubing, INDIGO Separator. The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, Select Catheter, and introducer. The INDIGO Separator may be provided with an introducer and torque device. The Select+ Catheter is an accessory within kitted configurations of the INDIGO Lightning Flash Aspiration System. The Select+ Catheter is used to aide in access to the site of occlusion and is removed prior to initiating aspiration with the aspiration catheter. The use of the Select+ Catheter to facilitate access to the site of the occlusion is an optional procedural step for INDIGO Lightning Flash Aspiration Catheters. The device is provided sterile and intended for single use only.

The MIDWAY Delivery Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The MIDWAY Delivery Catheters are single lumen percutaneous catheters designed to provide a conduit for introduction of interventional devices to the peripheral, coronary, and neuro vasculature. The MIDWAY Delivery Catheter is a single lumen, coil-reinforced, variable stiffness catheter with a radiopaque marker band on the distal end and a Luer hub on the proximal end. The MIDWAY Delivery Catheter is compatible with sheaths and guide catheters appropriately sized for the outer diameter of the MIDWAY Delivery Catheter. The MIDWAY Delivery Catheter has a hydrophilic coating on the distal segment of the catheter shaft.

INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The INDIGO® Aspiration System is comprised of the several devices: INDIGO Aspiration Catheter, Penumbra Aspiration Pump, INDIGO Aspiration Pump Canister, INDIGO Aspiration Tubing, INDIGO Separator. The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, Select Catheter, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

The Penumbra LP Coil System is indicated for the embolization of: - · Intracranial aneurysms - · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae - · Arterial and venous embolizations in the peripheral vasculature

The Penumbra LP Coil System is comprised of the Penumbra LP Coil, a platinum embolization coil attached to a composite delivery pusher with a radiopaque positioning marker and the Penumbra LP Coil Detachment Handle. The coil/delivery pusher is packaged separately from the Penumbra LP Coil Detachment Handle. Penumbra LP Coil includes the following coil configurations: - Ruby Coil LP ● - Packing Coil LP ● - PTC Coil LP ● - Helical Coil LP ● - Hybrid Coil LP ●