📋 FDA Reference
Scoutpro Slitter Tool Advanced Model 356 552
Summary: The scoutpro slitter tool advanced model 356 552 by Biotronik is a medical device used primarily in venous stenting procedures. It is utilized by interventional radiologists and vascular surgeons to facilitate the placement of stents in venous pathways.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K071665 ↗
Decision Date ?
July 18, 2007
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The scoutpro slitter tool advanced model 356 552 was cleared through the FDA 510(k) pathway on July 18, 2007. Manufactured by Biotronik, it is classified as a Class 2 device under product code DQY.
What It Is
The scoutpro slitter tool advanced model 356 552 is a specialized medical instrument designed to assist in the deployment of venous stents. It works by providing a precise and controlled method for slitting the sheath covering a stent, allowing for accurate placement within the vein. This tool is essential in procedures where precise stent deployment is critical to patient outcomes.
FDA-Cleared Indications
- Used as a percutaneous catheter accessory in vascular procedures under the FDA product code DQY.
- Intended for use with compatible catheter or sheath systems according to the manufacturer's labeling and instructions for use.
Clinical Applications
- Slitting or removing a compatible catheter or sheath during a percutaneous vascular procedure.
- Assisting catheter exchange or removal when the catheter or sheath must be opened rather than withdrawn over the guidewire.
- Use in catheterization laboratory procedures performed by trained vascular specialists.
Practical Considerations
- Confirm compatibility with the specific catheter, sheath, guidewire, and vascular access system before use.
- The device should be handled only by clinicians trained in percutaneous vascular procedures and catheter or sheath removal.
- Use appropriate fluoroscopic or other imaging guidance when required by the procedure and the manufacturer's instructions.
- The FDA record provided does not establish MRI safety; consult the current labeling before exposing the device or any retained component to an MRI environment.
- Potential complications depend on the underlying procedure and may include bleeding, vascular injury, infection, thrombosis, embolization, or incomplete device removal.
Procedures that use this device
Frequently Asked Questions
What is scoutpro slitter tool advanced model 356 552 used for?
It is used for facilitating the placement of venous stents in patients with venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the placement of venous stents to treat conditions like venous obstructions.
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.