The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Diaflex Occlusion Balloon Catheter.
| Device ID | K850790 |
| 510k Number | K850790 |
| Device Name: | DIAFLEX OCCLUSION BALLOON CATHETER |
| Classification | Catheter, Urological |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Ronald J Ehmsen |
| Correspondent | Ronald J Ehmsen AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-26 |
| Decision Date | 1985-03-25 |