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possis medical myopore bipolar sutureless mycardia
Possis Medical
Summary: The Possis Medical Myopore Bipolar Sutureless Myocardial is a Class III medical device used in cardiac surgery. It is designed for myocardial attachment without sutures, primarily used by cardiac surgeons.
FDA Clearance Information
Pathway
510K
Number
K925099 ↗
Decision Date
June 22, 1993
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared via the FDA 510(k) pathway on June 22, 1993, by Possis Medical. It is classified as a Class III device under product code DTB.
What It Is
The Possis Medical Myopore Bipolar Sutureless Myocardial is a specialized device used in cardiac surgery to facilitate myocardial attachment without the need for sutures. This device employs bipolar technology to secure myocardial tissue, potentially reducing procedure time and improving surgical outcomes. It is particularly useful in delicate cardiac procedures where precision and reduced trauma are paramount.
Clinical Applications
This device is commonly used in cardiac surgery, particularly in procedures requiring myocardial attachment, such as valve repair or replacement surgeries. It is primarily utilized in hospital settings by cardiac surgeons. The device is suitable for adult patients undergoing complex cardiac procedures where minimizing tissue trauma and reducing operative time are critical.
Indications for Use
The device is indicated for use in patients requiring myocardial attachment during cardiac surgery. It is particularly beneficial for those undergoing procedures where traditional suturing is challenging or time-consuming.
Practical Considerations
The device is designed to be compatible with standard cardiac surgical instruments. Surgeons should be familiar with bipolar technology and its application in myocardial tissue. Proper training in the device's use is recommended to ensure optimal outcomes.
Frequently Asked Questions
What is the Possis Medical Myopore Bipolar Sutureless Myocardial used for?
It is used for myocardial attachment in cardiac surgeries, eliminating the need for sutures.
What specialties typically use this device?
Cardiac surgeons primarily use this device in hospital settings during cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for myocardial attachment in cardiac surgeries, particularly where suturing is challenging.
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.