đź“‹ FDA Reference
delivery catheter sspc1 delivery catheter sspc2 delivery catheter sspc3 delivery catheter sspc4
Centerpoint Systems
Summary: The delivery catheter SSPC1-4 by Centerpoint Systems is used for the placement of venous stents. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K190475 ↗
Decision Date
June 28, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The delivery catheter SSPC1-4 received FDA clearance via the 510k pathway on June 28, 2019. Manufactured by Centerpoint Systems, it is classified as a Class 2 device under product code DQY.
What It Is
The delivery catheter SSPC1-4 is a medical device designed for the precise delivery and placement of venous stents. It consists of a flexible catheter that can navigate through the venous system to reach the target site. The device facilitates the deployment of stents to treat venous obstructions or insufficiencies, ensuring proper blood flow.
Clinical Applications
This device is commonly used in procedures involving the treatment of venous obstructions, such as deep vein thrombosis or chronic venous insufficiency. It is primarily utilized in hospital settings by interventional radiologists and vascular surgeons. The catheter aids in the accurate placement of stents in patients with compromised venous circulation, improving their vascular health.
Indications for Use
The FDA indications for this device include the delivery and placement of stents in the venous system. It is intended for patients with conditions that require venous stenting to restore or maintain adequate blood flow.
Practical Considerations
The delivery catheter SSPC1-4 is available in various sizes to accommodate different patient anatomies and stent sizes. It is compatible with standard stenting techniques and requires careful handling to ensure precise stent placement. Clinicians should be familiar with the catheter's navigation and deployment mechanisms.
Frequently Asked Questions
What is the delivery catheter SSPC1-4 used for?
It is used for the delivery and placement of venous stents to treat venous obstructions or insufficiencies.
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 the delivery and placement of venous stents to restore or maintain blood flow in patients with 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.