The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrac Tm Multipurpose Balloon Catheter.
| Device ID | K820646 |
| 510k Number | K820646 |
| Device Name: | ATRAC TM MULTIPURPOSE BALLOON CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | ATRIUM MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-09 |
| Decision Date | 1982-03-25 |