The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Forgarty Balloon Calibrator.
| Device ID | K830734 |
| 510k Number | K830734 |
| Device Name: | FORGARTY BALLOON CALIBRATOR |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-08 |
| Decision Date | 1983-04-12 |