📋 FDA Reference
Curity R Percutaneous Catheters
Kendall Healthcare Products Co. Div.Of Tyco Health
Summary: Curity R Percutaneous Catheters are medical devices used for venous access, primarily in vascular procedures. They are typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K895972 ↗
Decision Date ?
March 13, 1990
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Curity R Percutaneous Catheters were cleared through the FDA 510(k) pathway on March 13, 1990. Manufactured by Kendall Healthcare Products Co., these devices are classified as Class 2 under product code DQY.
What It Is
Curity R Percutaneous Catheters are designed for percutaneous access to the venous system, facilitating various vascular procedures. These catheters are inserted through the skin into a vein, allowing for the administration of medications, fluids, or for the placement of other devices such as stents. Their design ensures minimal trauma to the vessel wall and provides a reliable conduit for vascular interventions.
FDA-Cleared Indications
- Percutaneous access to the venous system for diagnostic or therapeutic procedures.
- Use as a conduit for the administration of fluids or medications.
- Use to facilitate the introduction or placement of other vascular devices.
Clinical Applications
- Percutaneous venous access during diagnostic vascular procedures.
- Venous access for infusion of medications or fluids.
- Access for procedures involving placement of other vascular devices.
- Venous interventions in which catheter-based access to the vessel is required.
Practical Considerations
- The appropriate catheter size and length depend on the target vein, patient anatomy, and planned procedure.
- Insertion should be performed using sterile technique and appropriate imaging guidance when indicated.
- The catheter must be compatible with the guidewires, introducers, syringes, and other equipment used for the procedure.
- Potential complications include bleeding, infection, thrombosis, vessel injury, air embolism, and catheter malfunction.
- MRI safety is not established from the available record; confirm the specific device labeling before an MRI examination.
Procedures that use this device
Frequently Asked Questions
What is Curity R Percutaneous Catheters used for?
They are used for venous access in vascular procedures, including medication delivery and stenting.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use these catheters.
What are the FDA-cleared indications?
They are indicated for percutaneous venous access for therapeutic or diagnostic procedures.
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.