Reservoir D744 D.A.C.
Reservoir D744 D.A.C. is a cardiotomy reservoir (FDA Class II; FDA product code DTP, Defoamer, cardiopulmonary bypass) made by Sorin Group Italia SRL, cleared under FDA 510(k) K844803 on 29 Apr 1985 and listed in FDA GUDID since 15 Jul 2015 (UDI-DI 08033178250160), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08033178250160 | Date15 Jul 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK844803 | Date29 Apr 1985 | StatusActive |
Official records
- AccessGUDID record 08033178250160
- FDA 510(k) database K844803
Across registries
- FDA 510(k) K844803 decided 29 Apr 1985 Active
- FDA GUDID UDI-DI 08033178250160 listed 15 Jul 2015 Listed
Timeline
- Cleared FDA 510(k) K844803
- Listed FDA GUDID 08033178250160
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Reservoir
- Generic name
- Cardiotomy reservoir
- Model / reference
- D744 D.A.C.
- Primary DI / UDI-DI
- 08033178250160
- 510(k) Number
- FDA product code
- DTP
- GMDN term
- Cardiotomy reservoir
- Device class
- Class II
- Regulation number
- 870.4230
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DTP (Defoamer, cardiopulmonary bypass).
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- SHILEY CARDIOTOMY RESERVOIR W/FILTER by Shiley, Inc.
- BARD FILTERED CARDIOTOMY RESERVOIR by C. R. Bard, Inc.
- VENOUS RESERVOIR-BMR-1500-HARD SHELL by American Bentley
- CARDIOTOMY RESERVOIR WITH FILTER by Travenol Laboratories, S.A.
- Cobe SmarXT VVR 4000 Filtered Hardshell Venous Reservoir by Cobe Cardiovascular, Inc.
- Mediastinal Autotransfusion System by Cardio Metrics, Inc.
- MCR4000 & MCR4000F Cardiotomy Reservoir by MEDTRONIC VASCULAR, INC.