The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Fogarty Softjaw 6mm Spring Clip, #614-06.
| Device ID | K810162 |
| 510k Number | K810162 |
| Device Name: | FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 |
| Classification | Clamp, Vascular |
| Applicant | AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-22 |
| Decision Date | 1981-02-04 |