The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Veinprep Vein Graft Prep. Kit A277723.
| Device ID | K830150 |
| 510k Number | K830150 |
| Device Name: | VEINPREP VEIN GRAFT PREP. KIT A277723 |
| Classification | Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Applicant | ATRIUM MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWD |
| CFR Regulation Number | 870.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-17 |
| Decision Date | 1983-02-28 |