Xvac
510(k) K110782
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110782 | Date7 Apr 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CAC
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5830
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Xvac is an Autotransfusion Apparatus, a medical device used for autotransfusion. It is classified as a class 2 device.
The Xvac is supplied with a regulation number of 868.5830 and is regulated by the FDA with a 510K clearance. It is used in the field of Anesthesiology and is manufactured by Sorin Group Italia S.R.L.
Other devices from Sorin Group Italia S.R.L.
Questions
AI-generated answers, 6 Oct 2026
What is the Xvac used for?
The Xvac is used for autotransfusion in the field of Anesthesiology, providing a medical device solution for patients requiring blood transfusions during surgical procedures.
Is the Xvac a single-use device?
The device data does not specify whether the Xvac is single-use or reusable, but as an autotransfusion apparatus, it is likely designed for multiple uses with proper sterilization and maintenance.
What regulatory clearance does the Xvac have?
The Xvac has FDA 510K clearance, indicating that it has been found to be substantially equivalent to a predicate device and has met the necessary regulatory requirements for market approval.
What is the regulation number for the Xvac?
The Xvac has a regulation number of 868.5830, which is a unique identifier assigned by the FDA for this medical device.