đź“‹ FDA Reference
greco-harvey surfactant bonded cath for anesthesio
Cook
Summary: The Greco-Harvey Surfactant Bonded Cath is a specialized catheter used in anesthesiology for tumor ablation procedures. It is primarily utilized by anesthesiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K851244 ↗
Decision Date
November 19, 1985
Product Code
KDQ
Device Class
Class 2
Evidence
0 studies
The Greco-Harvey Surfactant Bonded Cath was cleared through the FDA 510(k) pathway on November 19, 1985. Manufactured by Cook, it is classified as a Class 2 medical device.
What It Is
The Greco-Harvey Surfactant Bonded Cath is a catheter designed for use in anesthesiology, featuring a surfactant-bonded surface to enhance its performance in ablation procedures. This device is engineered to facilitate the delivery of anesthetic agents or other therapeutic substances directly to the target site, minimizing tissue trauma and improving procedural outcomes.
Clinical Applications
This catheter is commonly used in tumor ablation procedures, particularly in settings where precise delivery of anesthetic or therapeutic agents is critical. It is frequently employed by anesthesiologists and interventional radiologists in hospitals and specialized outpatient centers. The device is suitable for adult patients undergoing procedures that require targeted ablation of tumor tissues.
Indications for Use
The FDA indications suggest that this catheter is intended for use in procedures that involve the ablation of tumors. It is particularly useful in cases where precise delivery of agents is necessary to achieve optimal therapeutic outcomes.
Practical Considerations
Clinicians should consider the compatibility of this catheter with other devices used in ablation procedures. It is important to select the appropriate size for the patient's anatomy to ensure effective delivery and minimize complications. Proper technique in catheter placement is crucial for maximizing the device's benefits.
Related Literature
The linked study investigated the neuronal uptake of a nanoformulated enzyme designed to scavenge superoxide radicals, which are implicated in cardiovascular diseases like hypertension. The study demonstrated that central administration of this nanozyme could attenuate hypertension in an angiotensin II-dependent model. While promising, the study's limitations include its focus on a specific biochemical pathway and the need for further clinical trials to validate these findings in broader patient populations.
Frequently Asked Questions
What is the Greco-Harvey Surfactant Bonded Cath used for?
It is used for tumor ablation procedures, particularly in anesthesiology, to deliver therapeutic agents directly to the target site.
What specialties typically use this device?
Anesthesiologists and interventional radiologists commonly use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in ablation procedures involving tumors, where precise delivery of therapeutic agents is required.
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.