đź“‹ FDA Reference
pg pro microcatheter
Microvention, Inc. A Terumo Group
Summary: The pg pro microcatheter is a medical device used primarily in interventional radiology and endovascular procedures. It is designed for use by specialists such as interventional radiologists and vascular surgeons to facilitate the placement of venous stents.
FDA Clearance Information
Pathway 510K
Number K192625 ↗
Decision Date November 21, 2019
Product Code DQY
Device Class Class 2
Evidence 0 studies
The pg pro microcatheter, manufactured by Microvention, Inc., a Terumo Group, received FDA clearance via the 510k pathway on November 21, 2019. It is classified as a Class 2 device under product code DQY.
What It Is
The pg pro microcatheter is a specialized catheter used in minimally invasive procedures to navigate through the vascular system. It is designed to provide access to specific areas within the venous system, allowing for the delivery of stents or other therapeutic devices. Its micro size and flexibility make it suitable for navigating complex vascular anatomy, which is crucial in endovascular interventions.
Clinical Applications
This device is commonly used in procedures involving the placement of venous stents, particularly in cases of venous stenosis or occlusion. Interventional radiologists and vascular surgeons often use it in hospital settings, especially in catheterization labs. It is suitable for adult patients who require venous interventions due to conditions like deep vein thrombosis or chronic venous insufficiency.
Indications for Use
The FDA-cleared indications for the pg pro microcatheter include its use in facilitating the placement of venous stents. It is intended for patients with venous conditions that necessitate stenting to restore or maintain adequate blood flow.
Practical Considerations
When using the pg pro microcatheter, clinicians should consider its compatibility with other devices, such as guidewires and stents. It is typically available in various sizes to accommodate different patient anatomies and procedural requirements. Proper technique and familiarity with endovascular procedures are essential for optimal outcomes.
Frequently Asked Questions
What is pg pro microcatheter used for?
The pg pro microcatheter is used to facilitate the placement of venous stents in endovascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of venous stents in patients with venous conditions.
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.