📋 FDA Reference
Greco-Harvey Surfact Bond Cath Hyperalimentation
Summary: The Greco-Harvey Surf Bond Cath Hyperalimentation is a medical device used for catheter-based hyperalimentation procedures. It is typically used by healthcare professionals in settings requiring nutritional support via intravenous methods.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K851243 ↗
Decision Date ?
March 14, 1986
Product Code ?
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on March 14, 1986. Manufactured by Cook, it is classified as a Class 2 device under product code LJS.
What It Is
The Greco-Harvey Surf Bond Cath Hyperalimentation is a catheter designed for hyperalimentation, which involves providing nutrition intravenously to patients who cannot eat or absorb nutrients through the gastrointestinal tract. The device facilitates the delivery of nutrients directly into the bloodstream, ensuring that patients receive the necessary caloric intake and essential nutrients. Its design likely includes features that enhance the stability and ease of insertion, making it suitable for long-term nutritional support.
FDA-Cleared Indications
- Delivery of hyperalimentation or parenteral nutrition through long-term intravascular access.
- Nutritional support when oral or enteral feeding is inadequate or not possible.
- Long-term intravenous access for patients requiring nutritional therapy.
Clinical Applications
- Administration of intravenous nutrition to patients with inadequate gastrointestinal absorption.
- Parenteral nutritional support during prolonged inability to use the gastrointestinal tract.
- Long-term central venous access for hyperalimentation under the supervision of qualified healthcare professionals.
Practical Considerations
- The access vein, catheter length, and catheter diameter should be selected according to the patient's anatomy, therapy, and intended duration of use.
- Insertion and maintenance require sterile technique, appropriate imaging or other position-confirmation methods, and routine catheter-site monitoring.
- The catheter and infusion system must be checked for compatibility with the prescribed parenteral nutrition solution and other intravenous medications.
- Potential complications include infection, thrombosis, occlusion, malposition, vascular injury, air embolism, and catheter breakage; follow the current device labeling and institutional protocols.
- MRI safety cannot be determined from the FDA record alone. Confirm the exact catheter model and current manufacturer labeling before MRI, and do not assume that a catheter is MR safe or MR conditional.
Frequently Asked Questions
What is the Greco-Harvey Surf Bond Cath Hyperalimentation used for?
It is used for providing intravenous nutritional support to patients who cannot eat or absorb nutrients through their digestive system.
What specialties typically use this device?
Specialties such as gastroenterology, surgery, and critical care medicine typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing intravenous nutrition due to conditions like severe gastrointestinal disorders or post-surgical recovery.
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.