Expired: August 20222

Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ  tip, 85cm , 8Fr., Peripheral Thrombectomy  Mechanical one each

CAT8 Indigo Aspiration Catheter 8, TORQ  tip, 85cm , 8Fr., Peripheral Thrombectomy  Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ  tip, 85cm , 8Fr., Peripheral Thrombectomy  Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ  tip, 85cm , 8Fr., Peripheral Thrombectomy  Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ  tip, 85cm , 8Fr., Peripheral Thrombectomy  Mechanical one eachIndigo Aspiration Tubing – Indication For Use As part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo Aspiration Catheters to the Penumbra Pump MAX™

Contraindications Not for use in the coronaries or the neurovasculature.

Warnings

• The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques.

• Do not advance, retract or use any component of the Indigo System against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device or system as a unit. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel.

• Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump

Precautions

• The device is intended for single use only. Do not resterilize or reuse. Resterilization and/or Reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location.

• Do not use kinked or damaged devices. Do not use opened or damaged packages. Return all damaged devices and packaging to the manufacturer/distributor.

• Use prior to the “Use By” date.

• Use the Indigo Aspiration System in conjunction with fluoroscopic visualization.

• Maintain a constant infusion of appropriate flush solution.

• When performing aspiration ensure the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended.

• The Indigo Separator™ is not intended for use as a neurovascular guidewire. If repositioning of the Indigo Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard micro- catheter and guidewire techniques.

• Do not use automated high-pressure contrast injection equipment with the Indigo Aspiration Catheter because it may damage the device.