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gesco per-q-cath catheter introducer
Gesco Intl.
Summary: The Gesco Per-Q-Cath Catheter Introducer is a medical device used to facilitate the insertion of catheters into the vascular system. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K915167 ↗
Decision Date
January 27, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Gesco Per-Q-Cath Catheter Introducer was cleared by the FDA via the 510k pathway on January 27, 1992. It is manufactured by Gesco Intl. and classified as a Class 2 medical device.
What It Is
The Gesco Per-Q-Cath Catheter Introducer is a medical device designed to aid in the percutaneous introduction of catheters into the vascular system. It typically consists of a sheath and a dilator, which help in accessing veins or arteries with minimal trauma. This device is crucial in procedures requiring vascular access, ensuring that catheters can be placed accurately and safely.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is essential for procedures such as the placement of central venous catheters, PICC lines, and other vascular access devices. The introducer is particularly useful in patients requiring long-term intravenous therapy or hemodynamic monitoring, including those in critical care or oncology settings.
Indications for Use
The FDA indications for the Gesco Per-Q-Cath Catheter Introducer include its use in facilitating the insertion of catheters into the vascular system. It is suitable for patients needing vascular access for treatments such as chemotherapy, parenteral nutrition, or dialysis.
Practical Considerations
The device is available in various sizes to accommodate different catheter types and patient anatomies. Clinicians should ensure compatibility with the catheters being used and be familiar with the technique for percutaneous insertion to minimize complications such as bleeding or infection.
Frequently Asked Questions
What is the Gesco Per-Q-Cath Catheter Introducer used for?
It is used to facilitate the insertion of catheters into the vascular system, aiding in procedures like central venous catheter placement.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital and clinical settings.
What are the FDA-cleared indications?
The device is indicated for the introduction of catheters into the vascular system for patients requiring vascular 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.