The following data is part of a premarket notification filed by Exco, Inc. with the FDA for Intraflon, Intraflux, Intravalve.
| Device ID | K813144 |
| 510k Number | K813144 |
| Device Name: | INTRAFLON, INTRAFLUX, INTRAVALVE |
| Classification | Cannula, Catheter |
| Applicant | EXCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQR |
| CFR Regulation Number | 870.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-05 |
| Decision Date | 1981-11-27 |