The following data is part of a premarket notification filed by Endologix, Inc. with the FDA for Dual Lumen Catheter, Model Dl-35-90.
| Device ID | K991601 |
| 510k Number | K991601 |
| Device Name: | DUAL LUMEN CATHETER, MODEL DL-35-90 |
| Classification | Catheter, Percutaneous |
| Applicant | ENDOLOGIX, INC. 20 FAIRBANKS, SUITE #173 Irvine, CA 92618 |
| Contact | Karen U Salinas |
| Correspondent | Karen U Salinas ENDOLOGIX, INC. 20 FAIRBANKS, SUITE #173 Irvine, CA 92618 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-10 |
| Decision Date | 1999-10-28 |