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footprint medical 1 9 fr picc introducer
Footprint Medical
Summary: The Footprint Medical 1 9 Fr PICC Introducer is a medical device used to facilitate the insertion of peripherally inserted central catheters (PICCs). It is primarily used by interventional radiologists and vascular access specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K093026 ↗
Decision Date
February 24, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Footprint Medical 1 9 Fr PICC Introducer was cleared through the FDA 510(k) pathway on February 24, 2010. It is manufactured by Footprint Medical and classified as a Class 2 device under product code DYB.
What It Is
The Footprint Medical 1 9 Fr PICC Introducer is a specialized medical device designed to aid in the insertion of PICCs. It works by providing a stable and precise entry point into the vascular system, facilitating the placement of catheters that are used for long-term intravenous access. This device is critical in ensuring the safe and effective delivery of medications, nutrients, and other therapies directly into the bloodstream.
Clinical Applications
This device is commonly used in interventional radiology and vascular access procedures, particularly in patients requiring long-term intravenous therapy, such as chemotherapy, antibiotic treatment, or total parenteral nutrition. It is typically utilized in hospital settings, including intensive care units and oncology departments, where precise and reliable vascular access is crucial. The device is suitable for a wide range of patient populations, including pediatric and adult patients.
Indications for Use
The FDA indications for the Footprint Medical 1 9 Fr PICC Introducer include its use in facilitating the insertion of PICCs for patients needing long-term intravenous access. This is particularly important for patients undergoing treatments that require frequent administration of medications or nutrients.
Practical Considerations
The 1 9 Fr sizing of this introducer makes it compatible with a variety of PICC lines, offering flexibility in clinical practice. Clinicians should ensure proper technique during insertion to minimize complications such as infection or thrombosis. Compatibility with existing vascular access equipment should be verified prior to use.
Frequently Asked Questions
What is the Footprint Medical 1 9 Fr PICC Introducer used for?
It is used to facilitate the insertion of peripherally inserted central catheters (PICCs) for long-term intravenous access.
What specialties typically use this device?
Interventional radiologists and vascular access specialists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the insertion of PICCs for patients requiring long-term intravenous access.
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.