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mega pericardiocentesis kit
Mega Medical
Summary: The Mega Pericardiocentesis Kit is a medical device used to remove fluid from the pericardial sac. It is primarily used by cardiologists and emergency physicians in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K912564 ↗
Decision Date
September 5, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Mega Pericardiocentesis Kit was cleared through the FDA 510k pathway on September 5, 1991. It is manufactured by Mega Medical and classified as a Class 2 device under product code DQY.
What It Is
The Mega Pericardiocentesis Kit is a specialized medical device designed to facilitate the safe and effective removal of fluid from the pericardial sac, a procedure known as pericardiocentesis. The kit typically includes a needle, catheter, and drainage system, allowing clinicians to relieve pressure on the heart caused by fluid accumulation. This device is essential in managing cardiac tamponade and other conditions where fluid buildup impairs cardiac function.
Clinical Applications
This device is commonly used in emergency and critical care settings, particularly in cardiology and emergency medicine. It is crucial for treating patients with cardiac tamponade, a life-threatening condition where fluid accumulation exerts pressure on the heart. The kit is also used in diagnostic procedures to analyze pericardial fluid for infections, malignancies, or other pathological conditions. Patients who benefit from this device often present with symptoms such as chest pain, dyspnea, or hypotension.
Indications for Use
The FDA indications for the Mega Pericardiocentesis Kit include the removal of pericardial fluid in patients with suspected cardiac tamponade or other conditions causing pericardial effusion. It is used when there is a need to relieve pressure on the heart or to obtain fluid samples for diagnostic purposes.
Practical Considerations
Clinicians should be aware of the typical sizing of the needle and catheter included in the kit to ensure compatibility with patient anatomy. Proper aseptic technique is crucial to minimize infection risk. Familiarity with ultrasound guidance can enhance the safety and accuracy of the procedure.
Frequently Asked Questions
What is the Mega Pericardiocentesis Kit used for?
It is used to remove fluid from the pericardial sac, often in cases of cardiac tamponade or to obtain fluid for diagnostic analysis.
What specialties typically use this device?
Cardiologists and emergency physicians primarily use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the removal of pericardial fluid in conditions like cardiac tamponade and for diagnostic sampling of pericardial effusions.
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.