📋 FDA Reference
Footprint Medical 1 9 Fr PICC Introducer
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitation of peripherally inserted central catheter placement.
- Use as an introducer during vascular access procedures requiring PICC insertion.
Clinical Applications
- Insertion of PICCs for intravenous medication administration.
- Establishment of central venous access for prolonged antibiotic therapy.
- Establishment of central venous access for chemotherapy.
- Establishment of central venous access for parenteral nutrition or other prescribed intravenous therapies.
Practical Considerations
- The device is identified as a 9 Fr PICC introducer; clinicians should confirm the introducer dimensions and compatibility with the selected PICC and vascular access system before use.
- Insertion should be performed using appropriate sterile technique and, when indicated, ultrasound or fluoroscopic guidance.
- Potential vascular-access complications include bleeding, hematoma, infection, thrombosis, vessel injury and malposition.
- MRI safety information is not established by the provided FDA record. Review the current manufacturer labeling before an MRI examination.
- Contraindications, warnings, handling instructions and single-use requirements should be checked in the current product labeling.
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.