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penumbra aspiration pump model 115v
Penumbra
Summary: The Penumbra Aspiration Pump Model 115v is a medical device used for mechanical thrombectomy in venous systems. It is typically used by interventional radiologists and vascular surgeons to remove blood clots.
FDA Clearance Information
Pathway
510K
Number
K051758 ↗
Decision Date
August 17, 2005
Product Code
BTA
Device Class
Class 2
Evidence
0 studies
The Penumbra Aspiration Pump Model 115v was cleared via the FDA 510k pathway on August 17, 2005. It is manufactured by Penumbra and classified as a Class 2 device under product code BTA.
What It Is
The Penumbra Aspiration Pump Model 115v is a medical device designed to assist in the removal of thrombi or blood clots from the venous system. It operates by creating a vacuum to aspirate the clot through a catheter. This device is part of a broader category of mechanical thrombectomy tools that provide a minimally invasive option for treating venous thromboembolic conditions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in treating patients with deep vein thrombosis (DVT) or pulmonary embolism (PE), where rapid clot removal is necessary. The device is suitable for use in hospital settings, especially in catheterization labs, and is applicable to adult patients who require intervention for venous thromboembolic events.
Indications for Use
The FDA indications for the Penumbra Aspiration Pump Model 115v involve the removal of thrombi from the venous system. It is intended for patients who have conditions such as deep vein thrombosis or pulmonary embolism, where clot removal can alleviate symptoms and prevent complications.
Practical Considerations
The Penumbra Aspiration Pump Model 115v is compatible with various catheter sizes, allowing for flexibility in different clinical scenarios. Clinicians should ensure proper setup and calibration of the pump to achieve optimal aspiration performance. Familiarity with catheter navigation techniques is essential for effective use.
Frequently Asked Questions
What is the Penumbra Aspiration Pump Model 115v used for?
It is used for the removal of thrombi or blood clots from the venous system, particularly in cases of deep vein thrombosis or pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital settings, particularly in catheterization labs.
What are the FDA-cleared indications?
The device is cleared for the removal of thrombi from the venous system, addressing conditions like deep vein thrombosis and pulmonary embolism.
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.