The following data is part of a premarket notification filed by Pace Medical with the FDA for Model 4815 Adapter.
| Device ID | K002496 |
| 510k Number | K002496 |
| Device Name: | MODEL 4815 ADAPTER |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Contact | Robert C Mace |
| Correspondent | Robert C Mace PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-14 |
| Decision Date | 2000-10-10 |