D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir
by Dideco S.R.L. 510(k)
Active
510(k) K043323
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043323 | Date1 Feb 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0767-2012
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Specification
- 510(k) Number
- FDA Product Code
- DTZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4350
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent