đź“‹ FDA Reference
modification to biotronik s sterilization process
Biotronik
Summary: This device involves a modification to Biotronik's sterilization process, used for ensuring the safety and efficacy of their medical devices. It is primarily utilized by healthcare professionals involved in device implantation and management.
FDA Clearance Information
Pathway
510K
Number
K023803 ↗
Decision Date
December 11, 2002
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This modification to Biotronik's sterilization process was cleared through the FDA 510(k) pathway on December 11, 2002. It is manufactured by Biotronik and classified as a Class III device.
What It Is
The device refers to a modification in the sterilization process used by Biotronik for their medical devices. Sterilization is crucial for preventing infections and ensuring device safety. This process ensures that the devices meet stringent safety standards before being used in clinical settings.
Clinical Applications
The sterilization process is essential in settings where Biotronik devices are implanted, such as cardiology and interventional radiology. It is crucial for ensuring that devices like IVC filters are free from contaminants before being used in procedures that involve insertion into the body.
Indications for Use
The FDA indications suggest that this sterilization process is intended for use with devices like IVC filters, which are used to prevent pulmonary embolism in patients. It is crucial for patients requiring long-term device implantation.
Practical Considerations
Clinicians should ensure compatibility with existing Biotronik devices. The sterilization process is designed to maintain device integrity and functionality, which is critical for patient safety and device performance.
Frequently Asked Questions
What is the Biotronik sterilization process used for?
It is used to ensure that Biotronik devices are free from contaminants and safe for implantation.
What specialties typically use this device?
Specialties such as cardiology and interventional radiology commonly use devices sterilized by this process.
What are the FDA-cleared indications?
The process is indicated for use with devices like IVC filters to ensure they are safe for preventing 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.