📋 FDA Reference
Bard Parker Perfusion Catheter
Bd Becton Dickinson Vacutainer Systems Preanalytic
Summary: The Bard Parker Perfusion Catheter is a medical device used for venous access and perfusion in clinical settings. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K855201 ↗
Decision Date ?
April 29, 1986
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Bard Parker Perfusion Catheter was cleared through the FDA 510(k) pathway on April 29, 1986. It is manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic and classified as a Class 2 device.
What It Is
The Bard Parker Perfusion Catheter is a specialized catheter designed for venous access and perfusion. It facilitates the delivery of fluids, medications, or contrast agents directly into the venous system. The catheter is typically made of biocompatible materials to minimize the risk of thrombosis and infection, and it features a design that allows for efficient perfusion and fluid management.
FDA-Cleared Indications
- Percutaneous catheter access to blood vessels for perfusion.
- Delivery of fluids, medications, contrast media, or other agents when vascular access is required.
- Use in accordance with the specific catheter size, configuration, and instructions for use.
Clinical Applications
- Catheter-based venous access during selected vascular procedures.
- Perfusion or infusion of fluids and medications through vascular access.
- Administration of contrast material for diagnostic vascular imaging when compatible with the catheter configuration.
- Access during interventional procedures in patients for whom peripheral venous access is inadequate.
Practical Considerations
- The appropriate catheter size and length depend on the access vessel, patient anatomy, intended flow rate, and procedure.
- Use sterile technique and standard image-guided vascular access methods to reduce infection, bleeding, and vessel-injury risks.
- Confirm compatibility with the intended medication, contrast agent, infusion pressure, and connection system before use.
- MRI safety is configuration-specific; review the current product labeling and confirm whether the catheter is MR Safe, MR Conditional, or not evaluated before MRI.
- Potential complications include bleeding, hematoma, infection, thrombosis, embolization, vessel injury, malposition, and extravasation.
Procedures that use this device
Frequently Asked Questions
What is the Bard Parker Perfusion Catheter used for?
It is used for venous access and perfusion, allowing the delivery of fluids, medications, or contrast agents into the venous system.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in clinical settings.
What are the FDA-cleared indications?
The catheter is indicated for patients requiring venous access for fluid, medication, or diagnostic agent administration, especially when peripheral access is difficult.
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.