📋 FDA Reference
Spex LP Support Catheter
Summary: The Spex LP Support Catheter is a medical device used in vascular procedures, primarily by interventional radiologists and cardiologists. It assists in the placement and support of guidewires and other devices within the vascular system.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K200094 ↗
Decision Date ?
March 18, 2020
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Spex LP Support Catheter was cleared through the FDA's 510(k) pathway on March 18, 2020. Manufactured by Reflow Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Spex LP Support Catheter is a specialized catheter designed to provide support and facilitate the delivery of guidewires and other interventional devices within the vascular system. It is constructed to navigate through complex vascular anatomy, offering flexibility and support. This device is particularly useful in procedures requiring precise navigation and positioning within blood vessels.
FDA-Cleared Indications
- For percutaneous vascular procedures requiring catheter support and navigation.
- To support the placement and delivery of guidewires and other interventional devices within the vascular system.
Clinical Applications
- Providing support for guidewire placement during percutaneous vascular interventions.
- Facilitating delivery of other interventional devices through the vascular system.
- Supporting catheter and guidewire navigation through complex vascular anatomy.
- Use during endovascular treatment of narrowed or blocked blood vessels when additional device support is needed.
Practical Considerations
- Available sizes and configurations should be matched to the target vessel, access route and devices used in the procedure.
- The catheter is intended for use with compatible guidewires and interventional devices; clinicians should confirm compatibility before use.
- It requires fluoroscopic or other appropriate imaging guidance and should be handled by clinicians trained in percutaneous vascular procedures.
- The FDA record and supplied labeling should be consulted for MRI safety, contraindications, warnings and other device-specific restrictions; MRI status should not be assumed.
- As a catheter-based device, risks may include bleeding or hematoma at the access site, vessel injury, thrombosis, infection, embolization and complications related to contrast or sedation.
Procedures that use this device
Frequently Asked Questions
What is Spex LP Support Catheter used for?
It is used to support the placement of guidewires and other devices during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in vascular procedures to support the placement of guidewires and other interventional devices.
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.