đź“‹ FDA Reference
Pg Pro Microcatheter
Microvention, Inc. A Terumo Group
Product: Pg Pro — all models and sizes
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 ?
510(k)
Number ?
K192625 ↗
Decision Date ?
November 21, 2019
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Facilitation of venous stent placement.
- Use during percutaneous catheter-based procedures involving the venous system.
Clinical Applications
- Providing catheter access during venous stenting procedures.
- Facilitating placement of stents in narrowed or obstructed veins when venous stenting is clinically indicated.
- Supporting endovascular treatment of iliac or central venous obstruction when used as part of a venous stent procedure.
Practical Considerations
- The microcatheter must be compatible with the selected guidewire, delivery system, venous stent and other procedural equipment.
- Available sizes, lengths and configurations should be selected according to the target vessel, access route and patient anatomy.
- Use requires fluoroscopic or other appropriate imaging guidance by clinicians trained in percutaneous endovascular procedures.
- The FDA record provided does not establish that the device is independently MRI safe or MR conditional; consult the current manufacturer labeling before MRI.
- Contraindications, warnings and handling requirements should be reviewed in the current instructions for use. Potential catheter-procedure complications include bleeding, vessel injury, thrombosis, infection and device malfunction.
Procedures that use this device
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.