The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Tidal Distension Irrigation Set.
| Device ID | K841362 |
| 510k Number | K841362 |
| Device Name: | TIDAL DISTENSION IRRIGATION SET |
| Classification | Catheter, Irrigation |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-02 |
| Decision Date | 1984-08-02 |