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 |