📋 FDA Reference
Cps Aim Inner Catheter Models 410140 410141 410142 410144 410145 410146 410147 410148
Summary: The CPS Aim Inner Catheter is a medical device used in venous stenting procedures. It is typically utilized by interventional cardiologists and radiologists to facilitate the placement of stents in venous systems.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K053217 ↗
Decision Date ?
March 8, 2006
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The CPS Aim Inner Catheter models 410140 to 410148 were cleared through the FDA 510(k) pathway on March 8, 2006. Manufactured by St Jude Medical, this Class 2 device is classified under product code DQY.
What It Is
The CPS Aim Inner Catheter is a specialized catheter designed to assist in the placement of stents within the venous system. It features a flexible design to navigate the vascular anatomy and provide support for stent delivery. This device is integral in procedures requiring precise placement of stents to maintain venous patency.
FDA-Cleared Indications
- Use in percutaneous procedures involving the placement of venous stents.
- Use as a catheter to support access to the vascular system during an indicated endovascular intervention.
Clinical Applications
- Access and catheter support during placement of stents in the venous system.
- Endovascular treatment of a venous obstruction when placement of a venous stent is indicated.
- Placement of venous stents in anatomically appropriate central or peripheral venous segments, according to the device labeling and stent system instructions.
Practical Considerations
- Models 410140, 410141, 410142, and 410144 through 410148 may differ in size or configuration; users should verify the specific model and its instructions for use.
- The catheter must be compatible with the selected guidewire, access sheath, stent delivery system, and vessel anatomy.
- Insertion and positioning should be performed under appropriate fluoroscopic or other intravascular imaging guidance by trained clinicians.
- Potential concerns include vascular injury, bleeding, thrombosis, infection, embolization, catheter damage, and difficulty with advancement or removal.
- MRI safety and conditions should be confirmed from the current device labeling; this FDA record alone does not establish that the catheter is MR Safe or MR Conditional.
Procedures that use this device
Frequently Asked Questions
What is the CPS Aim Inner Catheter used for?
It is used for facilitating the placement of stents in the venous system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the placement of venous stents to treat venous obstructions or insufficiencies.
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.