The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Thoracic Catheter.
| Device ID | K831931 |
| 510k Number | K831931 |
| Device Name: | ATRIUM THORACIC CATHETER |
| Classification | Catheter, Cholangiography |
| Applicant | ATRIUM MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GBZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-15 |
| Decision Date | 1983-10-04 |