📋 FDA Reference
Enabler-P Catheter 1000 Part Number 1160
Endocross
Summary: The Enabler-P Catheter 1000, manufactured by Endocross, is a medical device used in venous stenting procedures. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K083833 ↗
Decision Date ?
May 22, 2009
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Enabler-P Catheter 1000 was cleared through the FDA 510(k) pathway on May 22, 2009. It is manufactured by Endocross and classified as a Class 2 device under product code DQY.
What It Is
The Enabler-P Catheter 1000 is a specialized catheter designed to assist in the placement of venous stents. It facilitates the navigation and deployment of stents within the venous system, helping to restore proper blood flow in patients with venous obstructions. The catheter's design allows for precise control and maneuverability, which is crucial during stenting procedures.
FDA-Cleared Indications
- Use as a percutaneous catheter in accordance with the device's cleared labeling.
- The available FDA summary does not provide a more specific vessel, procedure, or disease indication.
Clinical Applications
- Percutaneous catheter-based vascular procedures within the device's cleared labeling.
- Use by trained clinicians when catheter access and manipulation are required during an endovascular procedure.
Practical Considerations
- The supplied record does not state the catheter's available sizes, working length, lumen configuration, guidewire compatibility, or maximum pressure.
- Compatibility with a particular venous stent or other device should be confirmed in the current manufacturer instructions for use rather than assumed from the product name.
- MRI safety or MR conditional status is not provided in the available record; verify the current labeling before MRI exposure.
- Clinicians should review the current instructions for use for access-site requirements, contraindications, warnings, sterilization status, and handling limitations.
- The device should be used only by qualified clinicians familiar with percutaneous catheterization and the relevant vascular anatomy.
Procedures that use this device
Frequently Asked Questions
What is the Enabler-P Catheter 1000 used for?
It is used for assisting in the placement of venous stents to treat venous obstructions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting to treat vein narrowing or blockage.
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.