The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Fogarty Flexible Probe.
| Device ID | K812935 |
| 510k Number | K812935 |
| Device Name: | FOGARTY FLEXIBLE PROBE |
| Classification | Dilator, Vessel, Surgical |
| Applicant | AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWP |
| CFR Regulation Number | 870.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-20 |
| Decision Date | 1981-11-16 |