The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Flexible Visualization Catheter.
| Device ID | K862872 |
| 510k Number | K862872 |
| Device Name: | FLEXIBLE VISUALIZATION CATHETER |
| Classification | Instrument, Special Lens, For Endoscope |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Cole, Ph.d. |
| Correspondent | Cole, Ph.d. AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | FEI |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-30 |
| Decision Date | 1986-10-24 |