đź“‹ FDA Reference
Yoga Microcatheter 0 032 150cm Back Up and Extra Back Up
Codman & Shurtleff
Product: Yoga — all models and sizes
Summary: The Yoga Microcatheter is a specialized catheter used in endovascular procedures, particularly by interventional radiologists and vascular surgeons for venous stenting. It aids in navigating complex vascular pathways.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K171653 ↗
Decision Date ?
July 3, 2017
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Yoga Microcatheter received FDA clearance through the 510(k) pathway on July 3, 2017. Manufactured by Codman & Shurtleff, it is classified as a Class 2 medical device.
What It Is
The Yoga Microcatheter is a flexible, small-diameter catheter designed for precise navigation within the vascular system. Its 0.032-inch diameter and 150cm length make it suitable for accessing difficult-to-reach areas in the venous system. The device is engineered to provide backup support during procedures, enhancing stability and control for the clinician.
FDA-Cleared Indications
- Intended for percutaneous catheter-based vascular procedures requiring catheter access and support.
- Cleared for use in procedures involving venous stenting, according to the available FDA record summary.
Clinical Applications
- Catheter access during percutaneous venous stenting procedures.
- Navigation through narrow, tortuous, or difficult-to-reach venous anatomy during an indicated endovascular procedure.
- Providing backup support and catheter stability while compatible guidewires, stents, or other interventional devices are used.
Practical Considerations
- The listed configuration is 0.032 inches in diameter and 150 cm long; the Back Up and Extra Back Up designations indicate support configurations, not separate treatment indications.
- Use requires compatibility with the selected guidewire, introducer or guiding catheter, stent system, and imaging equipment.
- The catheter should be advanced under appropriate fluoroscopic or other image guidance by clinicians trained in percutaneous vascular procedures.
- The available record does not establish an MRI safety designation. Consult the current manufacturer labeling before MRI or exposure to the MR environment.
- Contraindications, warnings, maximum injection pressure, and other handling limits should be taken from the current manufacturer instructions for use.
Procedures that use this device
Frequently Asked Questions
What is the Yoga Microcatheter used for?
The Yoga Microcatheter is used for navigating and supporting procedures in the venous system, particularly for venous stenting.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device during endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures to help maintain or restore blood flow in the venous system.
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.