The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Cardiac Catherization Kit.
| Device ID | K914299 |
| 510k Number | K914299 |
| Device Name: | CARDIAC CATHERIZATION KIT |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Frederick Gustafson |
| Correspondent | Frederick Gustafson ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-25 |
| Decision Date | 1992-06-03 |