đź“‹ FDA Reference
Galt Vti Low Insertion Valve Tearaway Introducer
Summary: The Galt VTI Low Insertion Valve Tearaway Introducer is a medical device used primarily in interventional radiology and cardiology for vascular access. It is designed for clinicians performing procedures that require the introduction of catheters or other devices into the vascular system.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140028 ↗
Decision Date ?
August 21, 2014
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Galt VTI Low Insertion Valve Tearaway Introducer was cleared via the FDA 510k pathway on August 21, 2014. Manufactured by Galt Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Galt VTI Low Insertion Valve Tearaway Introducer is a specialized device used to facilitate the insertion of catheters or other medical instruments into the vascular system. It features a low insertion force valve and a tearaway sheath, which allows for smooth entry and removal of devices. This design minimizes trauma to the vessel and enhances procedural efficiency.
FDA-Cleared Indications
- Facilitation of percutaneous introduction of catheters and other intravascular devices into the vascular system.
- Provision of vascular access during procedures requiring catheter or device placement and exchange.
Clinical Applications
- Percutaneous vascular access for catheter-based procedures.
- Introduction of diagnostic or therapeutic catheters into blood vessels.
- Device exchange during interventional vascular procedures.
- Tearaway removal after the catheter or other intravascular device has been positioned.
Reported off-label uses
- Use as an access sheath during embolization procedures, including uterine, prostate, visceral, pelvic, or bronchial artery embolization.
- Use during transjugular procedures such as TIPS when the selected size and configuration are appropriate.
- Use for access in neurointerventional procedures when the device specifications and vascular anatomy are suitable.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The available sheath and dilator sizes should match the diameter of the planned catheter or device and the access vessel.
- The hemostasis valve is intended to reduce blood loss around an inserted device; clinicians should follow the manufacturer's instructions for insertion, flushing, and device exchange.
- The tearaway sheath must be split and removed using the manufacturer's recommended technique after the intravascular device is secured.
- MRI safety depends on the specific device materials, whether the introducer remains in place, and the manufacturer's current labeling. Confirm MR conditions before scanning.
- Potential complications of vascular introducer placement include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and contrast-related complications. Patient-specific contraindications and precautions should be assessed before use.
Procedures that use this device
Frequently Asked Questions
What is the Galt VTI Low Insertion Valve Tearaway Introducer used for?
It is used for introducing catheters or other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for facilitating the insertion of catheters and other devices into the vascular system, minimizing vessel trauma.
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.