đź“‹ FDA Reference
10600 deflectable catheter system model 10600
Medtronic Vascular
Summary: The 10600 Deflectable Catheter System by Medtronic Vascular is a medical device used primarily in venous stenting procedures. It is designed for use by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K013517 ↗
Decision Date
April 25, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 10600 Deflectable Catheter System was cleared through the FDA 510(k) pathway on April 25, 2002. Manufactured by Medtronic Vascular, it is classified as a Class 2 device under product code DQY.
What It Is
The 10600 Deflectable Catheter System is a specialized catheter designed to facilitate the placement of venous stents. It features a deflectable tip that allows for precise navigation through the vascular system. This system is particularly useful in complex venous anatomy where flexibility and control are crucial.
Clinical Applications
This catheter system is commonly used in interventional cardiology and radiology settings for procedures involving the placement of stents in the venous system. It is particularly beneficial in treating conditions such as venous obstructions or insufficiencies. The device is used in hospitals and specialized clinics, primarily for adult patients with venous diseases.
Indications for Use
The FDA indications for the 10600 Deflectable Catheter System include its use in procedures requiring venous stenting. It is intended for patients with conditions that necessitate the reinforcement of venous structures, such as chronic venous insufficiency or post-thrombotic syndrome.
Practical Considerations
The catheter system is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard stenting equipment and requires familiarity with catheter-based techniques for optimal use. Clinicians should ensure proper sizing and handling to maximize procedural success.
Frequently Asked Questions
What is 10600 Deflectable Catheter System used for?
It is used for the placement of venous stents in patients with venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in hospital and clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures, particularly for patients with 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.