The following data is part of a premarket notification filed by Endologix, Inc. with the FDA for Endologix Visiflex Dual Lumen Catheter.
| Device ID | K080360 |
| 510k Number | K080360 |
| Device Name: | ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ENDOLOGIX, INC. 11 STUDEBAKER Irvine, CA 92618 |
| Contact | Annaliza Victoria |
| Correspondent | Annaliza Victoria ENDOLOGIX, INC. 11 STUDEBAKER Irvine, CA 92618 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-11 |
| Decision Date | 2008-04-08 |
| Summary: | summary |