The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Edslab (r) Occlusion Balloon Catheter.
| Device ID | K873485 |
| 510k Number | K873485 |
| Device Name: | EDSLAB (R) OCCLUSION BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-31 |
| Decision Date | 1987-12-03 |