đź“‹ FDA Reference
penumbra ddc catheters
Penumbra
Summary: The Penumbra DDC Catheters are used for mechanical thrombectomy in venous systems, often by interventional radiologists or vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K122772 ↗
Decision Date
November 20, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Penumbra DDC Catheters were cleared via the FDA 510k pathway on November 20, 2012. Manufactured by Penumbra, this Class 2 device is classified under product code DQY.
What It Is
The Penumbra DDC Catheters are specialized medical devices designed for mechanical thrombectomy procedures. They work by navigating through the venous system to remove thrombi, or blood clots, using suction or other mechanical means. These catheters are essential tools in treating conditions like deep vein thrombosis, where clot removal is necessary to restore normal blood flow.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, these catheters are deployed in hospital settings, particularly in catheterization labs. They are crucial for patients with venous thromboembolic conditions, such as deep vein thrombosis or pulmonary embolism, where rapid clot removal can prevent complications. The device is also used in patients with venous stents to ensure patency and prevent re-occlusion.
Indications for Use
The FDA indications suggest that the Penumbra DDC Catheters are intended for patients with venous thromboembolic disorders requiring mechanical thrombectomy. This includes conditions where blood clots obstruct venous blood flow, necessitating intervention to restore circulation.
Practical Considerations
Clinicians should consider the catheter's size compatibility with the patient's venous anatomy. Proper technique involves careful navigation to the clot site, ensuring minimal trauma to the vessel walls. Familiarity with the device's operational mechanics is essential for effective use.
Frequently Asked Questions
What is Penumbra DDC Catheters used for?
The device is used for mechanical thrombectomy to remove blood clots from the venous system.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for mechanical thrombectomy in patients with venous thromboembolic disorders.
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.