Super Sheath™ Introducer Sheath
Indications, Safety and Warnings
Prescriptive Information
Super Sheath Introducer Sheath
INDICATIONS
This device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.
CONTRAINDICATIONS
None known.
PRECAUTION
This device is only to be used by a trained physician.
ADVERSE EVENTS
- Air embolism
- Infection
- Intimal tear
- Hemorrhage (hematoma or retroperitoneal bleed)
- Perforation of the vessel wall
- Thrombus formation, vessel occlusion
- AV fistula
- Emboli
- Pseudoaneurysm
Super Sheath XL Large Diameter
INDICATIONS
This device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.
CONTRAINDICATIONS
None known.
WARNING
NOTE: This product contains Di(2-ehylhexyl) phthalate (DEHP). Togo Medikit has conducted a Chemical Safety Assessment of DEHP in this device based on currently known acceptable exposure limits for sensitive populations (children and pregnant/nursing women), and has determined that the potential exposure is below the known acceptable exposure limits for the device when used in accordance with the indications and instructions for use.
PRECAUTION
This device is only to be used by a trained physician.
ADVERSE EVENTS
- Air embolism
- Infection
- Intimal tear
- Hemorrhage (hematoma or retroperitoneal bleed)
- Perforation of the vessel wall
- Thrombus formation
- vessel occlusion
- AV fistula
- Emboli
- Pseudoaneurysm
Super Sheath RO Introducer Sheath
INDICATIONS
This device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.
CONTRAINDICATIONS
None known.
PRECAUTION
This device is only to be used by a trained physician.
ADVERSE EVENTS
- Air embolism
- Infection
- Intimal tear
- Hemorrhage (hematoma or retroperitoneal bleed)
- Perforation of the vessel wall
- Thrombus formation
- vessel occlusion
- AV fistula
- Emboli
- Pseudoaneurysm