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Scoutpro 8f 7f and Slitter Tool Advanced
Summary: The scoutpro 8f 7f and slitter tool advanced is a venous stent system used primarily in vascular procedures. It is utilized by interventional radiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K072329 ↗
Decision Date ?
March 25, 2008
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The scoutpro 8f 7f and slitter tool advanced was cleared through the FDA 510(k) pathway on March 25, 2008. Manufactured by Biotronik, it is classified as a Class 2 device under product code DQY.
What It Is
The scoutpro 8f 7f and slitter tool advanced is a medical device designed for venous stenting procedures. It consists of a stent delivery system and a slitter tool, which facilitates the placement and deployment of stents in venous vessels. The device is engineered to provide support and maintain patency in veins that are narrowed or blocked, thereby improving blood flow.
FDA-Cleared Indications
- Use as a percutaneous catheter in vascular procedures, consistent with the FDA product classification.
- Refer to the device's current FDA-cleared labeling and instructions for use for the specific intended procedure and anatomy.
Clinical Applications
- Percutaneous catheter-based access or delivery during vascular intervention, when used according to the cleared labeling.
- Use by trained clinicians in an appropriately equipped catheterization or interventional procedure setting.
Practical Considerations
- The available record describes 7F and 8F device sizes; clinicians should confirm the exact configuration, working length, compatibility, and vessel-size requirements in the current instructions for use.
- Use compatible guidewires, sheaths, catheters, and other accessories specified by the manufacturer.
- Review contraindications, warnings, and handling instructions before use; risks of percutaneous vascular procedures include bleeding, infection, vessel injury, thrombosis, embolization, and contrast-related complications.
- MRI safety or conditional status cannot be determined from the supplied FDA summary. Confirm the current labeling before MRI exposure.
- The supplied record does not establish that this device itself is a venous stent or that it is indicated to treat venous obstruction; avoid inferring those uses without the original FDA labeling.
Frequently Asked Questions
What is scoutpro 8f 7f and slitter tool advanced used for?
It is used for placing stents in venous vessels to treat obstructions and improve blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for treating venous obstructions in patients with narrowed or blocked veins.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.