Catapult Guide Sheath 4f 15cm Us-34015-F-St-H Catapult Guide Sheath 4f 45cm Us-34045-F-St-H Catapult Guide Sheath 4f 60cm Us-34060-F-St-H Catapult Guide Sheath 4f 90cm Us-34090-F-St-H Catapult Guide Sheath 4f 130cm Us-34130-F-St-H Catapult Guide Sheath 5f 15cm Us-35015-F-St-H Catapult Guide Sheath 5f 45cm Us-35045-F-St-H Catapult Guide Sheath 5f 45cm Hockey Stick Us-35045-F-Hs-H Catapult Guide Sheath 5f 45cm Multipurpose Us-35045-F-Mp-H Ca

FDA-Cleared Indications

• For percutaneous introduction into blood vessels to facilitate the delivery of embolization coils and other compatible interventional devices.
• For use by physicians trained in vascular interventional procedures when selective vascular access and device delivery are required.

Clinical Applications

• Providing vascular access and support during embolization procedures.
• Facilitating delivery of embolization coils to target vessels.
• Supporting catheter and device navigation in peripheral and visceral vascular interventions.
• Providing a stable pathway during selected neurovascular embolization procedures when the sheath size and configuration are appropriate.

Reported off-label uses

• Use as an access or support sheath for delivery of other compatible interventional devices not specifically identified in the cleared labeling may occur in clinical practice, but this is off-label and depends on physician judgment and device compatibility.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• Available configurations include 4F and 5F sizes, with listed lengths from 15 cm to 130 cm; available 5F configurations include hockey-stick and multipurpose tip shapes.
• The operator should select sheath diameter, length, and tip configuration according to the access site, target vessel anatomy, required support, and compatibility with the planned catheter or embolic device.
• Use requires sterile technique, fluoroscopic or other appropriate imaging guidance, and clinicians trained in percutaneous vascular procedures.
• The supplied FDA record does not establish MRI safety; MRI conditions should be confirmed in the current manufacturer labeling before scanning a patient with the device in place.
• Potential concerns include vascular injury, bleeding, thrombosis, infection, vasospasm, dissection, embolization, and contrast-related complications. Contraindications and warnings should be reviewed in the current instructions for use.