đź“‹ FDA Reference
reverse 021 micro catheter reverse 027 micro catheter
Micro Therapeutics Inc., D/B/A Ev3 Neurovascular
Summary: The Reverse 021 and 027 Micro Catheters by Ev3 Neurovascular are specialized devices used in neurovascular procedures, primarily by interventional radiologists and neurosurgeons for accessing and treating venous conditions.
FDA Clearance Information
Pathway
510K
Number
K171268 ↗
Decision Date
May 31, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Reverse 021 and 027 Micro Catheters were cleared through the FDA 510k pathway on May 31, 2017. Manufactured by Micro Therapeutics Inc., these devices are classified as Class 2 under the product code DQY.
What It Is
The Reverse 021 and 027 Micro Catheters are flexible, small-diameter catheters designed for navigating the complex vascular structures of the brain. They facilitate the delivery of therapeutic agents or devices to targeted areas within the venous system. These catheters are engineered to provide optimal trackability and support, essential for precise interventions in neurovascular procedures.
Clinical Applications
These micro catheters are commonly used in neurointerventional procedures, such as embolization or stent placement, to treat conditions like arteriovenous malformations or venous stenosis. They are primarily utilized in hospital settings by interventional radiologists and neurosurgeons. The devices are suitable for adult patients requiring precise vascular access and treatment within the cerebral venous system.
Indications for Use
The FDA-cleared indications for these catheters involve their use in procedures requiring access to the venous system of the brain. They are intended for patients with conditions that necessitate the delivery of therapeutic devices or agents to specific venous sites.
Practical Considerations
The Reverse 021 and 027 Micro Catheters come in varying sizes to accommodate different vascular anatomies. They are compatible with standard guidewires and are designed for use with other neurovascular devices. Clinicians should be familiar with catheter navigation techniques to optimize procedural outcomes.
Frequently Asked Questions
What is the Reverse 021/027 Micro Catheter used for?
These catheters are used for accessing and treating venous conditions in the brain, facilitating the delivery of therapeutic agents or devices.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use these devices in neurovascular procedures.
What are the FDA-cleared indications?
The catheters are indicated for use in procedures requiring access to the venous system of the brain for therapeutic interventions.
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.