đź“‹ FDA Reference
Curity Percutaneous Catheter Insertion Kit
The Kendal
Summary: The Curity Percutaneous Catheter Insertion Kit is used for the placement of catheters in patients requiring vascular access. It is typically used by interventional radiologists and other specialists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K855061 ↗
Decision Date ?
April 16, 1986
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Curity Percutaneous Catheter Insertion Kit was cleared via the FDA 510(k) pathway on April 16, 1986. Manufactured by The Kendal, it is classified as a Class 2 device under product code DYB.
What It Is
The Curity Percutaneous Catheter Insertion Kit is a medical device designed for the insertion of catheters into the vascular system. It includes components necessary for percutaneous access, allowing clinicians to establish vascular access efficiently. This is crucial in procedures requiring long-term intravenous therapy or monitoring.
FDA-Cleared Indications
- Percutaneous insertion of catheters into the vascular system.
- Establishment of vascular access for clinical treatment or monitoring when catheter access is required.
Clinical Applications
- Obtaining percutaneous central venous access for intravenous medications and fluids.
- Establishing vascular access for hemodynamic monitoring.
- Catheter placement for patients receiving prolonged intravenous therapy, when consistent with the device labeling.
- Vascular access during hospital-based procedures performed by appropriately trained clinicians.
Practical Considerations
- The specific catheter sizes and components should be confirmed from the product packaging and current manufacturer instructions for use; the available record does not specify a complete size range.
- Use requires clinicians trained in percutaneous vascular access, sterile technique, catheter handling, and management of access-related complications.
- Confirm compatibility among the kit components, the selected catheter, infusion equipment, contrast or medications, and any guidewire or access system used.
- MRI safety cannot be determined from the FDA record alone. Review the current labeling for the specific kit and any implanted or retained catheter components before MRI.
- Patient-specific contraindications and precautions include infection at the access site, bleeding risk, thrombosis, abnormal anatomy, and inability to safely access the intended vessel.
Frequently Asked Questions
What is Curity Percutaneous Catheter Insertion Kit used for?
It is used for the insertion of catheters into the vascular system for patients requiring long-term intravenous access.
What specialties typically use this device?
Interventional radiologists, vascular surgeons, and critical care specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for establishing vascular access in patients needing intravenous therapy, fluid administration, or hemodynamic monitoring.
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.