The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Vein-trap Tm.
| Device ID | K811910 |
| 510k Number | K811910 |
| Device Name: | VEIN-TRAP TM |
| Classification | Stripper, Vein, External |
| Applicant | ATRIUM MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWQ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-20 |