DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
Device Facts
| Record ID | K945065 |
|---|---|
| Device Name | DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 |
| Applicant | Sorin Biomedical, Inc. |
| Product Code | DTN · Cardiovascular |
| Decision Date | May 19, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.
Special Controls
*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
