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saffron nm guiding catheter
Neich Medical (Shenzhen)
Summary: The Saffron NM Guiding Catheter is a medical device used primarily in interventional cardiology and radiology for guiding other instruments into the venous system. It is typically used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K030715 ↗
Decision Date
April 24, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Saffron NM Guiding Catheter was cleared through the FDA 510(k) pathway on April 24, 2003. Manufactured by Neich Medical (Shenzhen), it is classified as a Class 2 device under product code DQY.
What It Is
The Saffron NM Guiding Catheter is a flexible tube designed to facilitate the introduction of interventional devices into the venous system. It is constructed to provide support and stability while navigating through the vascular anatomy. The catheter's design allows for precise control and positioning, which is crucial during complex procedures.
Clinical Applications
This guiding catheter is commonly used in procedures involving venous stents, such as angioplasty or stent placement in the treatment of venous obstructions. It is particularly useful in interventional cardiology and radiology settings, where precise navigation and placement of devices are critical. Patients with conditions like deep vein thrombosis or venous insufficiency may benefit from procedures using this catheter.
Indications for Use
The FDA indications for the Saffron NM Guiding Catheter involve its use in guiding other medical devices into the venous system. It is intended for patients requiring interventional procedures to address venous blockages or abnormalities.
Practical Considerations
Clinicians should consider the catheter's compatibility with other devices and the specific anatomy of the patient when selecting the appropriate size. Proper technique in handling and positioning the catheter is essential to ensure successful outcomes and minimize complications.
Frequently Asked Questions
What is the Saffron NM Guiding Catheter used for?
It is used to guide interventional devices into the venous system during procedures like angioplasty or stent placement.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The catheter is indicated for guiding medical devices into the venous system, particularly in procedures addressing venous blockages.
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.