The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Vein Valve Cutter.
| Device ID | K862724 |
| 510k Number | K862724 |
| Device Name: | VEIN VALVE CUTTER |
| Classification | Catheter, Percutaneous |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Mark Cole |
| Correspondent | Mark Cole AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-17 |
| Decision Date | 1987-01-02 |