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Ts Percutaneous Arterial Venus Catheter Intro Set
Summary: The ts percutaneous arterial venous catheter intro set by C.R. Bard is used for vascular access in procedures requiring arterial and venous catheterization. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K955785 ↗
Decision Date ?
March 12, 1996
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The ts percutaneous arterial venous catheter intro set was cleared through the FDA 510(k) pathway on March 12, 1996, by C.R. Bard. It is classified as a Class 2 medical device.
What It Is
The ts percutaneous arterial venous catheter intro set is a medical device designed for establishing vascular access. It includes components necessary for the percutaneous introduction of catheters into the arterial and venous systems. This device facilitates procedures that require reliable access to the circulatory system, such as diagnostic angiography or therapeutic interventions.
FDA-Cleared Indications
- Percutaneous introduction of catheters into the arterial system.
- Percutaneous introduction of catheters into the venous system.
- Establishing vascular access for procedures requiring arterial or venous catheterization.
Clinical Applications
- Obtaining arterial access for diagnostic angiography.
- Obtaining venous access for diagnostic catheter procedures.
- Establishing access for vascular interventions requiring catheter placement.
Practical Considerations
- The appropriate sheath or catheter size should be selected based on the target vessel, patient anatomy and planned procedure.
- Confirm compatibility with guidewires, catheters and other interventional equipment before use.
- Use sterile technique and image guidance as appropriate to reduce bleeding, infection, vessel injury and other access-site complications.
- The FDA record provided does not specify MRI safety or conditional-use labeling; MRI compatibility should be confirmed in the current product labeling before scanning.
- Potential contraindications and precautions depend on the planned access site, vessel condition, bleeding risk, infection status and the components included in the specific set.
Procedures that use this device
Frequently Asked Questions
What is the ts percutaneous arterial venous catheter intro set used for?
It is used for establishing vascular access in procedures requiring arterial and venous catheterization.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing vascular access for arterial or venous procedures, such as embolization or other vascular 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.