📋 FDA Reference
Perfadex with Tham
Vitrolife Sweden Ab
Summary: Perfadex with THAM is a medical device used primarily in organ transplantation procedures, specifically lung transplants. It is utilized by transplant surgeons and healthcare teams to preserve donor lungs during transportation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K081997 ↗
Decision Date ?
October 9, 2008
Product Code ?
MSB
Device Class ?
Class 2
Evidence ?
0 studies
Perfadex with THAM was cleared through the FDA 510(k) pathway on October 9, 2008. Manufactured by Vitrolife Sweden Ab, it is classified as a Class 2 medical device.
What It Is
Perfadex with THAM is a preservation solution used in lung transplantation. It is designed to maintain the viability of donor lungs during transport from the donor to the recipient. The solution helps to reduce cellular damage by providing an optimal environment, including pH balance and osmotic conditions, to preserve lung tissue integrity.
FDA-Cleared Indications
- Preservation of donor lungs intended for transplantation.
- Maintenance of donor-lung viability during the period between organ recovery and transplantation.
Clinical Applications
- Flushing and preserving donor lungs during lung recovery for transplantation.
- Preserving donor lungs during transport from the donor hospital to the transplant center.
- Maintaining lung tissue during the interval before implantation into the recipient.
- Use during standard donor-lung preservation protocols at transplant centers.
Practical Considerations
- Perfadex with THAM is a preservation solution, not an implantable device or medication for treating the transplant recipient.
- Use requires transplant-center protocols for preparation, temperature control, flushing, storage and transport.
- It should be handled according to the manufacturer's labeling, including container integrity, expiration date and storage requirements.
- The solution is intended for donor-lung preservation and should not be assumed to be labeled for preserving other organs.
- MRI safety labeling is generally not applicable because the product is a liquid preservation solution rather than an implanted or electrically active device.
Frequently Asked Questions
What is Perfadex with THAM used for?
Perfadex with THAM is used for preserving donor lungs during transportation for transplantation.
What specialties typically use this device?
Transplant surgeons and healthcare professionals in organ transplant centers use this device.
What are the FDA-cleared indications?
Perfadex with THAM is indicated for the preservation of donor lungs for transplantation.
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.