Xres Blood Collection Reservoir
510(k) K100507
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100507 | Date24 Mar 2010 | 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- Withdrawn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
- DTN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4400
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The XRES Blood Collection Reservoir is a Reservoir, Blood, Cardiopulmonary Bypass device, classified as Class II under FDA regulations (870.4400). It is designed to collect, store, and manage blood during cardiopulmonary bypass procedures, ensuring efficient circulation and minimizing air embolism risk by filtering particles down to 120 micrometers. Constructed for use in cardiovascular surgery, it integrates with cardiopulmonary bypass systems to maintain blood integrity and flow during critical interventions.
Supplied as a sterile, single-use device, the XRES Blood Collection Reservoir is intended for hospital operating room use in cardiothoracic procedures. Each unit (reference 4275) is packaged in a box of 12, with expiration dates clearly marked on the lot. The device adheres to FDA 510(k) clearance (K100507) and is regulated under the Cardiovascular specialty category. Storage requires adherence to manufacturer guidelines to preserve sterility and functionality prior to use.
Other devices from Sorin Group Italia S.R.L.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the XRES Blood Collection Reservoir?
The XRES Blood Collection Reservoir is designed to collect, store, and manage blood during cardiopulmonary bypass (CPB) procedures. Its key function is to maintain efficient blood circulation while minimizing the risk of air embolism by filtering particles down to 120 micrometers. This ensures blood integrity and safety during critical cardiovascular surgeries.
How is the XRES Blood Collection Reservoir supplied, and what should I check before use?
The XRES Blood Collection Reservoir is supplied as a sterile, single-use device. Each unit is packaged in a box containing 12 reservoirs, with expiration dates clearly marked on the lot. Before use, verify the expiration date and ensure the packaging remains intact to confirm sterility and functionality.
Is the XRES Blood Collection Reservoir reusable, or is it intended for one-time use?
The XRES Blood Collection Reservoir is explicitly designed for single-use only. This design choice ensures patient safety by preventing contamination or degradation of the device between uses, which could compromise its performance or introduce risks during surgery.
What storage guidelines should be followed for the XRES Blood Collection Reservoir?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically includes keeping it in its original packaging, away from direct sunlight or extreme temperatures, and in a clean, dry environment. Avoid storing it in areas prone to moisture or contamination, such as near cleaning chemicals or operating room surfaces.
What regulatory approval does the XRES Blood Collection Reservoir hold, and under which category?
The XRES Blood Collection Reservoir holds FDA 510(k) clearance (K100507) and is classified under the Cardiovascular specialty category. It is regulated under the product code DTN and falls under FDA classification 870.4400 for Reservoir, Blood, Cardiopulmonary Bypass devices.