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primero safe access system
South53
Summary: The Primero Safe Access System is a medical device used for embolization procedures, primarily by interventional radiologists. It provides a safe and efficient way to access and treat vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K252441 ↗
Decision Date
September 29, 2025
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Primero Safe Access System by South53 was cleared through the FDA 510k pathway on September 29, 2025. It is classified as a Class 2 device under product code DYB.
What It Is
The Primero Safe Access System is a specialized medical device designed for use in embolization procedures. It facilitates the delivery of embolization coils to target vascular sites, aiding in the occlusion of blood vessels. This system is engineered to provide precise control and safety during vascular interventions, making it a valuable tool in managing conditions such as aneurysms or arteriovenous malformations.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures aimed at treating aneurysms, arteriovenous malformations, and other vascular abnormalities. The system is suitable for use in hospitals and specialized clinics, catering to adult and pediatric patient populations requiring embolization therapy.
Indications for Use
The FDA-cleared indications for the Primero Safe Access System include its use in embolization procedures to treat vascular abnormalities. It is intended for patients who require occlusion of blood vessels due to conditions such as aneurysms or arteriovenous malformations.
Practical Considerations
The Primero Safe Access System is typically available in various sizes to accommodate different vascular anatomies. It is compatible with standard embolization coils and requires familiarity with vascular access techniques. Clinicians should consider patient-specific factors such as vessel size and condition when selecting the appropriate device configuration.
Frequently Asked Questions
What is the Primero Safe Access System used for?
The Primero Safe Access System is used for embolization procedures to treat vascular abnormalities such as aneurysms and arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital and specialized clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to occlude blood vessels in conditions like aneurysms and arteriovenous malformations.
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.