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guidant retriever device
Guidant Cardiac And Vascular Surgery
Summary: The Guidant Retriever Device is a medical tool used for retrieving and removing venous stents. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K001694 ↗
Decision Date
May 15, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Guidant Retriever Device was cleared through the FDA 510(k) pathway on May 15, 2001. It is manufactured by Guidant Cardiac And Vascular Surgery and classified as a Class 2 device.
What It Is
The Guidant Retriever Device is designed to assist in the retrieval and removal of venous stents. It operates by engaging the stent structure and allowing for its extraction from the venous system. This device is crucial in situations where stent repositioning or removal is necessary due to complications or misplacement.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the correction of stent misplacement or addressing complications such as stent migration or thrombosis. Patients with venous stents that require adjustment or removal are typical candidates for procedures involving this device.
Indications for Use
The FDA indications for the Guidant Retriever Device include the retrieval and removal of venous stents. It is intended for use in patients who have had complications with their venous stents, such as migration or thrombosis.
Practical Considerations
The Guidant Retriever Device is available in various sizes to accommodate different stent dimensions and venous anatomies. It is compatible with standard interventional radiology equipment and requires familiarity with endovascular techniques for optimal use.
Frequently Asked Questions
What is the Guidant Retriever Device used for?
It is used for retrieving and removing venous stents, particularly in cases of stent misplacement or complications.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the retrieval and removal of venous stents in patients experiencing complications such as migration or thrombosis.
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.