The following data is part of a premarket notification filed by Dideco with the FDA for Dideco D901 Lilliput Hollow Fiber Oxygenator With Or Without Soft Venous Reservoir Bag, With Biocompatable Treatment Sur.
| Device ID | K010478 |
| 510k Number | K010478 |
| Device Name: | DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | DIDECO 14401 W. 65th Way Arvada, CO 80004 -3599 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard DIDECO 14401 W. 65th Way Arvada, CO 80004 -3599 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-20 |
| Decision Date | 2001-09-27 |